A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion (COMINO)

• ClinicalTrials.gov Identifier: NCT04740931
• Recruitment Status: Completed
• First Posted: February 5, 2021
• Results First Posted: January 18, 2024
• Last Update Posted: January 18, 2024
• Sponsor: Hoffmann-La Roche
• Collaborator: Chugai Pharmaceutical
• Information provided by (Responsible Party): Hoffmann-La Roche

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Macular Edema; Central Retinal Vein Occlusion; Hemiretinal Vein Occlusion
• Interventions: Drug: Faricimab; Drug: Aflibercept; Procedure: Sham Procedure
• Enrollment: 729

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)	Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
Arm/Group Description	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Period Title: Overall Study
Started [1]	366	363
Received at Least One Dose of Study Drug [2]	365	361
Completed up to Week 24 (Part 1) [3]	360	353
Completed	0	0
Not Completed	366	363
Reason Not Completed
Ongoing in the Study at the Primary Completion Date	360	353
Withdrawal by Subject	0	4
Death	1	2
Noncompliance with study drug	2	0
Reason Not Specified	2	0
Adverse Event	1	1
Protocol Violation	0	1
Physician Decision	0	1
Lost to Follow-up	0	1
[1] Intent-to-Treat (ITT) Population; [2] Safety-Evaluable Population; [3] Clinical Cutoff for Primary Completion Date

Baseline Characteristics

Arm/Group Title		Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)	Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)	Total
Arm/Group Description		In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).	Total of all reporting groups
Overall Number of Baseline Participants		366	363	729
Baseline Analysis Population Description		ITT Population: All global participants who were randomized in the study, according to the assigned treatment.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	366 participants	363 participants	729 participants
		65.6 (13.1)	64.7 (13.3)	65.1 (13.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	366 participants	363 participants	729 participants
	Female	173 47.3%	163 44.9%	336 46.1%
	Male	193 52.7%	200 55.1%	393 53.9%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	366 participants	363 participants	729 participants
	Hispanic or Latino	66 18.0%	73 20.1%	139 19.1%
	Not Hispanic or Latino	286 78.1%	283 78.0%	569 78.1%
	Unknown or Not Reported	14 3.8%	7 1.9%	21 2.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	366 participants	363 participants	729 participants
	American Indian or Alaska Native	2 0.5%	3 0.8%	5 0.7%
	Asian	89 24.3%	88 24.2%	177 24.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 0.3%	1 0.1%
	Black or African American	10 2.7%	13 3.6%	23 3.2%
	White	243 66.4%	253 69.7%	496 68.0%
	More than one race	1 0.3%	0 0.0%	1 0.1%
	Unknown or Not Reported	21 5.7%	5 1.4%	26 3.6%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	366 participants	363 participants	729 participants
	Rest of World	187 51.1%	187 51.5%	374 51.3%
	USA and Canada	95 26.0%	93 25.6%	188 25.8%
	Asia	84 23.0%	83 22.9%	167 22.9%
Number of Participants by the Eye (Left or Right) Chosen as the Study Eye; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	366 participants	363 participants	729 participants
	Left Eye	180 49.2%	181 49.9%	361 49.5%
	Right Eye	186 50.8%	182 50.1%	368 50.5%
Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye; Mean (Standard Deviation); Unit of measure: ETDRS Letters
	Number Analyzed	366 participants	363 participants	729 participants
		50.25 (16.25)	50.71 (16.34)	50.48 (16.29)
Number of Participants by the BCVA Letter Score Categories in the Study Eye; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	366 participants	363 participants	729 participants
	≤34 Letters (20/200 or Worse)	79 21.6%	80 22.0%	159 21.8%
	>34 Letters to <55 Letters	106 29.0%	105 28.9%	211 28.9%
	≥55 Letters (20/80 or Better)	181 49.5%	178 49.0%	359 49.2%

Outcome Measures

1. Primary Outcome

Title	Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
Time Frame	From Baseline through Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Mean (95% Confidence Interval); Unit of Measure: ETDRS Letters
	16.9; (15.4 to 18.3)	17.3; (15.9 to 18.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Faricimab Q4W (Part 1), Arm B: Aflibercept Q4W (Part 1)
	Comments	The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) >-4 letters. The final sample size provided >90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).
	Type of Statistical Test	Non-Inferiority
	Comments	If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.
Method of Estimation	Estimation Parameter	Difference in Adjusted Means
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -2.5 to 1.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.04
	Estimation Comments	The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm A: Faricimab Q4W (Part 1), Arm B: Aflibercept Q4W (Part 1)
	Comments	The final sample size provided >80% power for a 3.5-letter superiority assessment of faricimab over aflibercept (at a two-sided 0.0497 significance level).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6715
	Comments	Tested at a two-sided p<0.0497 significance level.
	Method	Mixed Model of Repeated Measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Adjusted Means
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -2.5 to 1.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.04
	Estimation Comments	The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.

2. Secondary Outcome

Title	Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Mean (95% Confidence Interval); Unit of Measure: ETDRS Letters
Week 4	13.5; (12.5 to 14.6)	14.3; (13.2 to 15.4)
Week 8	15.5; (14.4 to 16.7)	16.5; (15.3 to 17.7)
Week 12	16.9; (15.7 to 18.2)	17.1; (15.8 to 18.4)
Week 16	16.8; (15.4 to 18.1)	17.5; (16.2 to 18.9)
Week 20	17.0; (15.6 to 18.3)	17.2; (15.8 to 18.5)
Week 24	16.9; (15.4 to 18.3)	17.3; (15.9 to 18.8)

3. Secondary Outcome

Title	Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	From Baseline through Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	56.6; (51.7 to 61.5)	58.1; (53.3 to 62.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Faricimab Q4W (Part 1), Arm B: Aflibercept Q4W (Part 1)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in CMH Weighted Percentage
	Estimated Value	-1.5
	Confidence Interval	(2-Sided) 95%; -8.4 to 5.3
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	41.5; (36.7 to 46.3)	45.4; (40.7 to 50.2)
Week 8	51.1; (46.3 to 55.9)	53.7; (48.9 to 58.5)
Week 12	54.6; (49.8 to 59.4)	55.1; (50.3 to 59.9)
Week 16	57.7; (52.8 to 62.5)	59.5; (54.7 to 64.3)
Week 20	56.6; (51.7 to 61.4)	57.8; (53.0 to 62.6)
Week 24	56.6; (51.7 to 61.5)	58.1; (53.3 to 62.9)

5. Secondary Outcome

Title	Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	60.9; (56.0 to 65.8)	62.3; (57.6 to 66.9)
Week 8	69.1; (64.5 to 73.7)	72.8; (68.3 to 77.2)
Week 12	73.2; (68.8 to 77.7)	74.7; (70.3 to 79.0)
Week 16	73.5; (69.1 to 78.0)	75.8; (71.4 to 80.1)
Week 20	72.4; (68.0 to 76.9)	74.1; (69.7 to 78.5)
Week 24	72.2; (67.7 to 76.6)	73.3; (68.8 to 77.7)

6. Secondary Outcome

Title	Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	83.1; (79.3 to 86.9)	83.5; (79.7 to 87.2)
Week 8	85.2; (81.7 to 88.8)	86.8; (83.3 to 90.2)
Week 12	87.4; (84.1 to 90.8)	87.1; (83.7 to 90.5)
Week 16	86.3; (82.9 to 89.8)	88.7; (85.5 to 92.0)
Week 20	84.1; (80.5 to 87.8)	86.5; (83.0 to 90.0)
Week 24	85.3; (81.8 to 88.8)	84.6; (80.9 to 88.2)

7. Secondary Outcome

Title	Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	92.1; (89.4 to 94.8)	95.6; (93.5 to 97.7)
Week 8	92.1; (89.4 to 94.8)	94.8; (92.5 to 97.0)
Week 12	93.2; (90.6 to 95.7)	92.6; (89.9 to 95.2)
Week 16	92.6; (90.0 to 95.3)	92.0; (89.3 to 94.8)
Week 20	90.5; (87.5 to 93.4)	91.4; (88.6 to 94.3)
Week 24	90.5; (87.5 to 93.4)	89.2; (86.1 to 92.4)

8. Secondary Outcome

Title	Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	98.4; (97.1 to 99.7)	98.9; (97.8 to 100.0)
Week 8	98.1; (96.7 to 99.5)	98.1; (96.7 to 99.5)
Week 12	98.6; (97.5 to 99.8)	97.5; (95.9 to 99.1)
Week 16	97.3; (95.6 to 98.9)	97.0; (95.2 to 98.7)
Week 20	97.0; (95.3 to 98.7)	96.7; (94.9 to 98.5)
Week 24	96.2; (94.3 to 98.1)	96.7; (94.9 to 98.5)

9. Secondary Outcome

Title	Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	98.1; (96.7 to 99.5)	98.6; (97.4 to 99.8)
Week 8	97.5; (96.0 to 99.1)	97.5; (95.9 to 99.1)
Week 12	97.8; (96.3 to 99.3)	97.0; (95.2 to 98.7)
Week 16	95.9; (93.9 to 97.9)	96.1; (94.2 to 98.1)
Week 20	96.7; (94.9 to 98.5)	96.1; (94.2 to 98.1)
Week 24	95.1; (92.9 to 97.3)	95.9; (93.8 to 97.9)

10. Secondary Outcome

Title	Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	97.0; (95.3 to 98.7)	98.1; (96.7 to 99.5)
Week 8	96.2; (94.2 to 98.1)	96.4; (94.5 to 98.3)
Week 12	95.9; (93.9 to 97.9)	96.1; (94.2 to 98.1)
Week 16	95.4; (93.2 to 97.5)	94.8; (92.5 to 97.0)
Week 20	94.8; (92.6 to 97.1)	93.9; (91.5 to 96.4)
Week 24	94.0; (91.6 to 96.4)	93.7; (91.2 to 96.1)

11. Secondary Outcome

Title	Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	6.0; (3.6 to 8.4)	4.7; (2.6 to 6.8)
Week 8	8.7; (5.9 to 11.5)	10.2; (7.2 to 13.2)
Week 12	10.9; (7.8 to 14.0)	11.9; (8.7 to 15.0)
Week 16	11.5; (8.4 to 14.6)	14.1; (10.7 to 17.5)
Week 20	14.2; (10.9 to 17.6)	14.9; (11.4 to 18.3)
Week 24	14.5; (11.0 to 17.9)	15.2; (11.7 to 18.7)

12. Secondary Outcome

Title	Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	45.0; (41.0 to 49.1)	46.1; (41.9 to 50.2)
Week 8	48.6; (44.3 to 52.8)	54.6; (50.5 to 58.7)
Week 12	54.9; (50.8 to 58.9)	55.7; (51.4 to 60.0)
Week 16	54.9; (50.6 to 59.1)	59.3; (55.2 to 63.4)
Week 20	54.1; (49.7 to 58.4)	57.6; (53.4 to 61.8)
Week 24	55.7; (51.3 to 60.0)	59.0; (54.5 to 63.4)

13. Secondary Outcome

Title	Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Description	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	10.0; (7.3 to 12.8)	8.6; (6.1 to 11.1)
Week 8	8.2; (5.5 to 10.8)	7.0; (4.6 to 9.4)
Week 12	7.3; (4.9 to 9.8)	6.4; (4.0 to 8.8)
Week 16	7.8; (5.3 to 10.4)	6.2; (3.8 to 8.5)
Week 20	8.4; (5.7 to 11.0)	6.4; (4.0 to 8.8)
Week 24	10.1; (7.1 to 13.0)	7.5; (4.9 to 10.1)

14. Secondary Outcome

Title	Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Description	Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the Bruch's membrane (BM) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Mean (95% Confidence Interval); Unit of Measure: microns
Week 4	-420.8; (-429.2 to -412.5)	-417.3; (-425.6 to -409.0)
Week 8	-444.2; (-452.7 to -435.7)	-437.5; (-446.1 to -429.0)
Week 12	-451.0; (-460.6 to -441.5)	-442.5; (-452.1 to -433.0)
Week 16	-452.5; (-461.8 to -443.1)	-445.2; (-454.7 to -435.8)
Week 20	-459.4; (-467.8 to -451.0)	-445.1; (-453.6 to -436.6)
Week 24	-461.6; (-471.4 to -451.9)	-448.8; (-458.6 to -439.0)

15. Secondary Outcome

Title	Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Description	Absence of diabetic macular edema was defined as achieving a central subfield thickness of <325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	83.8; (80.2 to 87.5)	82.4; (78.5 to 86.2)
Week 8	92.6; (90.0 to 95.2)	91.2; (88.3 to 94.1)
Week 12	93.4; (90.9 to 95.9)	91.5; (88.6 to 94.3)
Week 16	94.5; (92.2 to 96.8)	92.8; (90.2 to 95.5)
Week 20	94.8; (92.6 to 97.1)	93.1; (90.5 to 95.7)
Week 24	93.7; (91.2 to 96.2)	92.0; (89.2 to 94.7)

16. Secondary Outcome

Title	Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Description	Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	45.5; (40.6 to 50.5)	40.3; (35.6 to 45.0)
Week 8	63.1; (58.3 to 68.0)	61.7; (56.9 to 66.6)
Week 12	53.2; (48.3 to 58.2)	51.0; (46.2 to 55.9)
Week 16	55.4; (50.5 to 60.3)	51.9; (46.8 to 56.9)
Week 20	59.0; (54.0 to 63.9)	56.5; (51.6 to 61.5)
Week 24	76.2; (71.9 to 80.5)	70.8; (66.2 to 75.4)

17. Secondary Outcome

Title	Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Description	Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	66.1; (61.4 to 70.8)	65.0; (60.3 to 69.7)
Week 8	89.6; (86.5 to 92.6)	90.1; (87.0 to 93.1)
Week 12	94.0; (91.6 to 96.4)	93.9; (91.5 to 96.4)
Week 16	95.3; (93.2 to 97.5)	95.6; (93.5 to 97.7)
Week 20	95.9; (93.9 to 97.9)	94.5; (92.2 to 96.8)
Week 24	96.4; (94.6 to 98.3)	93.4; (90.8 to 95.9)

18. Secondary Outcome

Title	Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Description	Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55, <55->34, and ≤34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline, Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	366	363
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 4	33.0; (28.3 to 37.6)	29.3; (24.9 to 33.7)
Week 8	59.3; (54.4 to 64.1)	59.3; (54.3 to 64.2)
Week 12	52.7; (47.7 to 57.6)	50.2; (45.3 to 55.1)
Week 16	54.9; (49.9 to 59.8)	51.3; (46.3 to 56.3)
Week 20	58.2; (53.2 to 63.1)	55.4; (50.5 to 60.4)
Week 24	75.1; (70.8 to 79.5)	68.6; (63.8 to 73.4)

19. Secondary Outcome

Title	Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24
Description	The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the ANCOVA analysis, the model uses the non-missing change from baseline in BCVA at Weeks 24 as the response variables adjusted for the treatment group, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA score (≥55 and ≤54 letters) and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were not imputed. 95% CI is a rounding of 95.03% CI.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing Baseline and Week 24 assessments were included for analysis.

Arm/Group Title	Arm A: Faricimab Q4W (Part 1)	Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description:	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Overall Number of Participants Analyzed	339	330
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	6.9; (5.8 to 8.0)	8.1; (7.0 to 9.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Faricimab Q4W (Part 1), Arm B: Aflibercept Q4W (Part 1)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Adjusted Means
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) 95%; -2.7 to 0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.77
	Estimation Comments	[Not Specified]

20. Secondary Outcome

Title	Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

21. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

22. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

23. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

24. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

25. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

26. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

27. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

28. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

29. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

30. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

31. Secondary Outcome

Title	Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline, Weeks 24, 48, and 72

Outcome Measure Data Not Reported

32. Secondary Outcome

Title	Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

33. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

34. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

35. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

36. Secondary Outcome

Title	Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Baseline and every 4 weeks from Week 4 to Week 72

Outcome Measure Data Not Reported

37. Secondary Outcome

Title	Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Every 4 weeks from Week 24 to Week 72

Outcome Measure Data Not Reported

38. Secondary Outcome

Title	Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Every 4 weeks from Week 24 to Week 72

Outcome Measure Data Not Reported

39. Secondary Outcome

Title	Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Every 4 weeks from Week 24 to Week 72

Outcome Measure Data Not Reported

40. Secondary Outcome

Title	Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Every 4 weeks from Week 24 to Week 72

Outcome Measure Data Not Reported

41. Secondary Outcome

Title	Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Description	[Not Specified]
Time Frame	Every 4 weeks from Week 24 to Week 72

Outcome Measure Data Not Reported

42. Secondary Outcome

Title	Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Description	[Not Specified]
Time Frame	Week 68

Outcome Measure Data Not Reported

43. Secondary Outcome

Title	Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72
Description	[Not Specified]
Time Frame	From Week 24 to Week 72

Outcome Measure Data Not Reported

44. Secondary Outcome

Title	Incidence and Severity of Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale
Description	[Not Specified]
Time Frame	From Baseline until end of study (up to 72 weeks)

Outcome Measure Data Not Reported

45. Secondary Outcome

Title	Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale
Description	[Not Specified]
Time Frame	From Baseline until end of study (up to 72 weeks)

Outcome Measure Data Not Reported

46. Secondary Outcome

Title	Plasma Concentration of Faricimab Over Time
Description	[Not Specified]
Time Frame	Predose at Day 1, Weeks 4, 24, 28, 52, and 72

Outcome Measure Data Not Reported

47. Secondary Outcome

Title	Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study
Description	[Not Specified]
Time Frame	Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72

Outcome Measure Data Not Reported

Adverse Events

Time Frame	From first dose up to Week 24
Adverse Event Reporting Description	Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are specified to have occurred in either the study eye or the fellow eye. At primary analysis, AEs were still being collected until the end of the study and the results will be updated within 1 year of the final collection date.
Arm/Group Title	Arm A: Faricimab Q4W (Part 1)		Arm B: Aflibercept Q4W (Part 1)
Arm/Group Description	In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).		In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
All-Cause Mortality
	Arm A: Faricimab Q4W (Part 1)		Arm B: Aflibercept Q4W (Part 1)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	1/365 (0.27%)		2/361 (0.55%)
Serious Adverse Events
	Arm A: Faricimab Q4W (Part 1)		Arm B: Aflibercept Q4W (Part 1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/365 (8.77%)		33/361 (9.14%)
Cardiac disorders
Acute myocardial infarction † 1	1/365 (0.27%)	1	1/361 (0.28%)	1
Bradycardia † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Cardiac failure † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Cardiac failure congestive † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Coronary artery disease † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Myocardial infarction † 1	0/365 (0.00%)	0	3/361 (0.83%)	3
Endocrine disorders
Thyroid mass † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Eye disorders
Cataract † 1 [1]	1/365 (0.27%)	1	0/361 (0.00%)	0
Cystoid macular oedema † 1 [2]	2/365 (0.55%)	2	2/361 (0.55%)	2
Macular ischaemia † 1 [2]	1/365 (0.27%)	1	0/361 (0.00%)	0
Macular oedema † 1 [2]	0/365 (0.00%)	0	1/361 (0.28%)	1
Non-infectious endophthalmitis † 1 [2]	0/365 (0.00%)	0	1/361 (0.28%)	1
Retinal artery embolism † 1 [2]	0/365 (0.00%)	0	1/361 (0.28%)	1
Retinal artery occlusion † 1 [2]	2/365 (0.55%)	2	1/361 (0.28%)	1
Retinal ischaemia † 1 [2]	1/365 (0.27%)	1	2/361 (0.55%)	2
Retinal tear † 1 [2]	0/365 (0.00%)	0	1/361 (0.28%)	1
Retinal vein occlusion † 1 [2]	1/365 (0.27%)	1	1/361 (0.28%)	1
Rhegmatogenous retinal detachment † 1 [2]	1/365 (0.27%)	1	0/361 (0.00%)	0
Uveitis † 1 [2]	2/365 (0.55%)	2	0/361 (0.00%)	0
Visual acuity reduced † 1 [2]	1/365 (0.27%)	1	0/361 (0.00%)	0
Vitreous haemorrhage † 1 [2]	1/365 (0.27%)	1	0/361 (0.00%)	0
Retinal vein occlusion † 1 [1]	0/365 (0.00%)	0	1/361 (0.28%)	1
Gastrointestinal disorders
Duodenal bulb deformity † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Duodenitis † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Gastritis erosive † 1	0/365 (0.00%)	0	1/361 (0.28%)	2
Haematochezia † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Inguinal hernia † 1	2/365 (0.55%)	2	0/361 (0.00%)	0
Obstructive pancreatitis † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Peptic ulcer † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
General disorders
Chest pain † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Hepatobiliary disorders
Bile duct stone † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Cholecystitis acute † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Gallbladder disorder † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Hepatic steatosis † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Infections and infestations
COVID-19 † 1	3/365 (0.82%)	3	0/361 (0.00%)	0
Endophthalmitis † 1 [2]	0/365 (0.00%)	0	1/361 (0.28%)	1
Gastroenteritis † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Osteomyelitis † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Osteomyelitis acute † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Pneumonia † 1	2/365 (0.55%)	2	1/361 (0.28%)	1
Pyelonephritis † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Sepsis † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Injury, poisoning and procedural complications
Eye injury † 1 [2]	1/365 (0.27%)	1	0/361 (0.00%)	0
Fall † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Shunt occlusion † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Investigations
Intraocular pressure increased † 1 [2]	0/365 (0.00%)	0	1/361 (0.28%)	1
Metabolism and nutrition disorders
Diabetic ketoacidosis † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Type 2 diabetes mellitus † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Lumbar spinal stenosis † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Osteonecrosis † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Gastric cancer † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Squamous cell carcinoma of the oral cavity † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Nervous system disorders
Altered state of consciousness † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Cerebrovascular accident † 1	2/365 (0.55%)	3	1/361 (0.28%)	1
Peripheral sensorimotor neuropathy † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Transient ischaemic attack † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Calculus urinary † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Chronic kidney disease † 1	1/365 (0.27%)	1	1/361 (0.28%)	1
Urethral stenosis † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Reproductive system and breast disorders
Uterine haemorrhage † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease † 1	1/365 (0.27%)	1	1/361 (0.28%)	1
Dyspnoea † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Pickwickian syndrome † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Pulmonary embolism † 1	1/365 (0.27%)	1	1/361 (0.28%)	1
Pulmonary hypertension † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Respiratory failure † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Skin and subcutaneous tissue disorders
Diabetic foot † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
Surgical and medical procedures
Knee operation † 1	0/365 (0.00%)	0	1/361 (0.28%)	2
Vascular disorders
Hypertensive crisis † 1	1/365 (0.27%)	1	0/361 (0.00%)	0
Orthostatic hypotension † 1	0/365 (0.00%)	0	1/361 (0.28%)	1
1 Term from vocabulary, MedDRA version 25.0; † Indicates events were collected by systematic assessment; [1] AEs occurred in the fellow eye; [2] AEs occurred in the study eye
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	3%
	Arm A: Faricimab Q4W (Part 1)		Arm B: Aflibercept Q4W (Part 1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/365 (14.79%)		51/361 (14.13%)
Eye disorders
Conjunctival haemorrhage † 1 [1]	10/365 (2.74%)	11	14/361 (3.88%)	14
Vitreous detachment † 1 [1]	11/365 (3.01%)	11	9/361 (2.49%)	9
Infections and infestations
COVID-19 † 1	13/365 (3.56%)	13	12/361 (3.32%)	12
Investigations
Intraocular pressure increased † 1 [1]	8/365 (2.19%)	10	12/361 (3.32%)	21
Vascular disorders
Hypertension † 1	13/365 (3.56%)	13	10/361 (2.77%)	10
1 Term from vocabulary, MedDRA version 25.0; † Indicates events were collected by systematic assessment; [1] AEs occurred in the study eye

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

• Name/Title: Medical Communications
• Organization: Hoffmann-La Roche
• Phone: 800-821-8590
• EMail: genentech@druginfo.com

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT04740931
• Other Study ID Numbers: GR41986; 2020-000441-13 ( EudraCT Number )
• First Submitted: February 3, 2021
• First Posted: February 5, 2021
• Results First Submitted: November 22, 2023
• Results First Posted: January 18, 2024
• Last Update Posted: January 18, 2024