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A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration (CEDAR)

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ClinicalTrials.gov Identifier: NCT02462928
Recruitment Status : Completed
First Posted : June 4, 2015
Results First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Macular Degeneration
Interventions Drug: Abicipar Pegol
Drug: Ranibizumab
Other: Sham Procedure
Enrollment 939
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4)
Hide Arm/Group Description Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered. Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered. Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Period Title: Overall Study
Started 314 313 312
Completed 224 221 255
Not Completed 90 92 57
Reason Not Completed
Screen Failure:Missed Exclusion Criteria             1             1             2
Adverse Event             47             51             25
Lack of Efficacy             3             8             3
Lost to Follow-up             4             4             1
Withdrawal by Patient             31             21             21
Protocol Violation             0             1             0
Reason not Specified             4             6             5
Arm/Group Title Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4) Total
Hide Arm/Group Description Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered. Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered. Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96. Total of all reporting groups
Overall Number of Baseline Participants 314 313 312 939
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 314 participants 313 participants 312 participants 939 participants
75.5  (8.4) 76.9  (8.0) 77.1  (8.4) 76.5  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 313 participants 312 participants 939 participants
Female
162
  51.6%
183
  58.5%
169
  54.2%
514
  54.7%
Male
152
  48.4%
130
  41.5%
143
  45.8%
425
  45.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 313 participants 312 participants 939 participants
White
249
  79.3%
248
  79.2%
243
  77.9%
740
  78.8%
Black
2
   0.6%
1
   0.3%
1
   0.3%
4
   0.4%
Asian
49
  15.6%
44
  14.1%
45
  14.4%
138
  14.7%
Hispanic
12
   3.8%
12
   3.8%
11
   3.5%
35
   3.7%
Not Reported
2
   0.6%
8
   2.6%
12
   3.8%
22
   2.3%
Best-corrected Visual Acuity (BCVA) Per Per-protocol Population   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 265 participants 262 participants 290 participants 817 participants
56.7  (13.3) 56.3  (13.1) 56.5  (12.6) 56.5  (13.0)
[1]
Measure Description: BCVA was measured using eye chart and reported as number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in study eye. Lower number of letters read correctly on eye chart, worse the vision (or visual acuity). Study eye is defined as eye that meets entry criteria. If both eyes met entry criteria, eye with worse BCVA at baseline (Day 1) was selected as study eye. If both eyes had same BCVA values at baseline (Day 1), then participant had to select their non-dominant eye for treatment, or else right eye was selected as study eye.
[2]
Measure Analysis Population Description: The per-protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately.
BCVA Per ITT Population   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 313 participants 313 participants 312 participants 938 participants
56.4  (13.4) 56.5  (12.9) 56.5  (12.5) 56.5  (12.9)
[1]
Measure Description: BCVA was measured using eye chart and reported as number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in study eye. Lower number of letters read correctly on eye chart, worse the vision (or visual acuity). Study eye is defined as eye that meets entry criteria. If both eyes met entry criteria, eye with worse BCVA at baseline (Day 1) was selected as study eye. If both eyes had same BCVA values at baseline (Day 1), then participant had to select their non-dominant eye for treatment, or else right eye was selected as study eye.
[2]
Measure Analysis Population Description: Number analyzed is the number of participants with data available at Baseline.
Central Retinal Thickness (CRT)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Microns
Number Analyzed 313 participants 313 participants 312 participants 938 participants
384.7  (142.7) 378.4  (119.1) 378.2  (120.5) 380.4  (127.8)
[1]
Measure Description: CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
[2]
Measure Analysis Population Description: Number analyzed is the number of participants with data available at Baseline.
National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)   [1] [2] 
Mean (Full Range)
Unit of measure:  Score on a scale
Number Analyzed 313 participants 313 participants 311 participants 937 participants
78.7
(28 to 98)
77.3
(34 to 98)
77.1
(23 to 100)
77.7
(23 to 100)
[1]
Measure Description: NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales.
[2]
Measure Analysis Population Description: Number analyzed is the number of participants with data available at Baseline.
1.Primary Outcome
Title Percentage of Participants With Stable Vision at Week 52
Hide Description Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately.
Arm/Group Title Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4)
Hide Arm/Group Description:
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Overall Number of Participants Analyzed 265 262 290
Measure Type: Number
Unit of Measure: percentage of participants
91.7 91.2 95.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abicipar Pegol 2 mg (2Q8), Ranibizumab 0.5 mg (rQ4)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -3.8
Confidence Interval (2-Sided) 95.1%
-8.2 to 0.3
Estimation Comments The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs >55 letters) as stratification factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abicipar Pegol 2 mg (2Q12), Ranibizumab 0.5 mg (rQ4)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -4.2
Confidence Interval (2-Sided) 95.1%
-8.7 to 0.0
Estimation Comments The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs >55 letters) as stratification factor.
2.Secondary Outcome
Title Mean Change From Baseline in BCVA in the Study Eye at Week 52
Hide Description BCVA was measured using an eye chart and was reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their nondominant eye for treatment, or else the right eye was selected as the study eye. Mixed model for repeated measures (MMRM) analysis was used.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately. Number of participants analyzed was based on observed data; missing data were not imputed.
Arm/Group Title Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4)
Hide Arm/Group Description:
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Overall Number of Participants Analyzed 241 239 272
Mean (Standard Deviation)
Unit of Measure: letters
6.7  (12.9) 5.6  (13.3) 8.5  (13.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abicipar Pegol 2 mg (2Q8), Ranibizumab 0.5 mg (rQ4)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is > - 5.0 letters.
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -2.4
Confidence Interval (2-Sided) 95.1%
-4.7 to -0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2
Estimation Comments MMRM included treatment, region, BL BCVA, BL CRT ≤400 or >400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abicipar Pegol 2 mg (2Q12), Ranibizumab 0.5 mg (rQ4)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is > - 5.0 letters.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.7
Confidence Interval (2-Sided) 95.1%
-6.0 to -1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2
Estimation Comments MMRM included treatment, region, BL BCVA, BL CRT ≤400 or >400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.
3.Secondary Outcome
Title Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
Hide Description CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye. MMRM analysis was used.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Number of participants analyzed was based on observed data; missing data were not imputed.
Arm/Group Title Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4)
Hide Arm/Group Description:
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Overall Number of Participants Analyzed 242 235 269
Mean (Standard Deviation)
Unit of Measure: microns
-141.5  (136.4) -150.1  (127.4) -141.3  (122.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abicipar Pegol 2 mg (2Q8), Ranibizumab 0.5 mg (rQ4)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 8.6
Confidence Interval (2-Sided) 95.1%
-3.8 to 20.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.3
Estimation Comments MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abicipar Pegol 2 mg (2Q12), Ranibizumab 0.5 mg (rQ4)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.3
Confidence Interval (2-Sided) 95.1%
-10.1 to 14.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.3
Estimation Comments MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.
4.Secondary Outcome
Title Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52
Hide Description BCVA was measured using an eye chart and reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4)
Hide Arm/Group Description:
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Overall Number of Participants Analyzed 314 313 312
Measure Type: Number
Unit of Measure: percentage of participants
22.6 19.2 27.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abicipar Pegol 2 mg (2Q8), Ranibizumab 0.5 mg (rQ4)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -4.7
Confidence Interval (2-Sided) 95.1%
-11.5 to 2.1
Estimation Comments The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs >55 letters) as the stratification factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abicipar Pegol 2 mg (2Q12), Ranibizumab 0.5 mg (rQ4)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -8.2
Confidence Interval (2-Sided) 95.1%
-14.7 to -1.5
Estimation Comments The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs >55 letters) as the stratification factor.
5.Secondary Outcome
Title Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52
Hide Description NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye was defined as eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Number of participants analyzed was based on observed data; missing data were not imputed.
Arm/Group Title Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4)
Hide Arm/Group Description:
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Overall Number of Participants Analyzed 250 253 273
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
2.7  (0.7) 3.7  (0.7) 4.6  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abicipar Pegol 2 mg (2Q8), Ranibizumab 0.5 mg (rQ4)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95.1%
-3.7 to -0.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.9
Estimation Comments MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abicipar Pegol 2 mg (2Q12), Ranibizumab 0.5 mg (rQ4)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95.1%
-2.7 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.9
Estimation Comments MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.
Time Frame From first dose to last dose of study drug (Up to Week 104)
Adverse Event Reporting Description Safety population included all treated participants.
 
Arm/Group Title Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4)
Hide Arm/Group Description Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered. Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered. Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
All-Cause Mortality
Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/312 (2.56%)   7/312 (2.24%)   11/310 (3.55%) 
Hide Serious Adverse Events
Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   92/312 (29.49%)   102/312 (32.69%)   95/310 (30.65%) 
Blood and lymphatic system disorders       
Anaemia † 1  1/312 (0.32%)  2/312 (0.64%)  4/310 (1.29%) 
Neutropenia † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Pancytopenia † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Iron deficiency anaemia † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Cardiac disorders       
Atrial fibrillation † 1  3/312 (0.96%)  4/312 (1.28%)  4/310 (1.29%) 
Coronary artery disease † 1  1/312 (0.32%)  2/312 (0.64%)  3/310 (0.97%) 
Cardiac failure congestive † 1  2/312 (0.64%)  3/312 (0.96%)  2/310 (0.65%) 
Acute myocardial infarction † 1  1/312 (0.32%)  3/312 (0.96%)  2/310 (0.65%) 
Angina pectoris † 1  0/312 (0.00%)  1/312 (0.32%)  2/310 (0.65%) 
Cardiac failure † 1  1/312 (0.32%)  0/312 (0.00%)  2/310 (0.65%) 
Arrhythmia † 1  0/312 (0.00%)  0/312 (0.00%)  2/310 (0.65%) 
Angina unstable † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Atrioventricular block second degree † 1  1/312 (0.32%)  0/312 (0.00%)  1/310 (0.32%) 
Myocardial infarction † 1  1/312 (0.32%)  0/312 (0.00%)  1/310 (0.32%) 
Aortic valve incompetence † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Cardiac disorder † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Cardiomyopathy † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Hypertensive heart disease † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Supraventricular tachycardia † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Ventricular tachycardia † 1  0/312 (0.00%)  2/312 (0.64%)  0/310 (0.00%) 
Left ventricular failure † 1  1/312 (0.32%)  1/312 (0.32%)  0/310 (0.00%) 
Mitral valve incompetence † 1  1/312 (0.32%)  1/312 (0.32%)  0/310 (0.00%) 
Aortic valve stenosis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Mitral valve prolapse † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Myocardial ischaemia † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Arteriosclerosis coronary artery † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Atrial flutter † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Cardiac tamponade † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Eye disorders       
Retinal artery occlusion † 1  1/312 (0.32%)  3/312 (0.96%)  1/310 (0.32%) 
Retinal haemorrhage † 1  4/312 (1.28%)  1/312 (0.32%)  1/310 (0.32%) 
Neovascular age-related macular degeneration † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Retinal pigment epithelial tear † 1  1/312 (0.32%)  0/312 (0.00%)  1/310 (0.32%) 
Macular degeneration † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Vitreous haemorrhage † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Uveitis † 1  10/312 (3.21%)  10/312 (3.21%)  0/310 (0.00%) 
Iridocyclitis † 1  1/312 (0.32%)  4/312 (1.28%)  0/310 (0.00%) 
Retinal vasculitis † 1  6/312 (1.92%)  3/312 (0.96%)  0/310 (0.00%) 
Visual acuity reduced † 1  4/312 (1.28%)  3/312 (0.96%)  0/310 (0.00%) 
Vitritis † 1  5/312 (1.60%)  2/312 (0.64%)  0/310 (0.00%) 
Cataract † 1  3/312 (0.96%)  1/312 (0.32%)  0/310 (0.00%) 
Autoimmune uveitis † 1  2/312 (0.64%)  1/312 (0.32%)  0/310 (0.00%) 
Eye pain † 1  1/312 (0.32%)  1/312 (0.32%)  0/310 (0.00%) 
Macular fibrosis † 1  1/312 (0.32%)  1/312 (0.32%)  0/310 (0.00%) 
Ocular hypertension † 1  1/312 (0.32%)  1/312 (0.32%)  0/310 (0.00%) 
Age-related macular degeneration † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Iritis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Macular scar † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Optic disc haemorrhage † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Optic ischaemic neuropathy † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Vitreous adhesions † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Retinal detachment † 1  3/312 (0.96%)  0/312 (0.00%)  0/310 (0.00%) 
Dacryostenosis acquired † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Diplopia † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Glaucoma † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Lacrimation increased † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Necrotising retinitis † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Photopsia † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Retinal oedema † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Retinal tear † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Retinal vein occlusion † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Subretinal fibrosis † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Visual impairment † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal haemorrhage † 1  1/312 (0.32%)  1/312 (0.32%)  2/310 (0.65%) 
Colitis † 1  0/312 (0.00%)  0/312 (0.00%)  2/310 (0.65%) 
Abdominal pain upper † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Vomiting † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Constipation † 1  1/312 (0.32%)  0/312 (0.00%)  1/310 (0.32%) 
Femoral hernia incarcerated † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Functional gastrointestinal disorder † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Gingival bleeding † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Haematochezia † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Inguinal hernia † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Intestinal infarction † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Obstructive pancreatitis † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Rectal haemorrhage † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Small intestinal obstruction † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Nausea † 1  0/312 (0.00%)  2/312 (0.64%)  0/310 (0.00%) 
Abdominal pain † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Anal fistula † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Colitis ischaemic † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Diarrhoea † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Gastritis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Gastrointestinal polyp haemorrhage † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Haemorrhoids † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Oesophageal stenosis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Barrett's oesophagus † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Haematemesis † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Incarcerated inguinal hernia † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Oesophageal spasm † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
General disorders       
Non-cardiac chest pain † 1  2/312 (0.64%)  0/312 (0.00%)  1/310 (0.32%) 
Death † 1  1/312 (0.32%)  0/312 (0.00%)  1/310 (0.32%) 
Pyrexia † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Asthenia † 1  1/312 (0.32%)  1/312 (0.32%)  0/310 (0.00%) 
Chest pain † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Multiple organ dysfunction syndrome † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Fatigue † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Oedema peripheral † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Hepatobiliary disorders       
Cholecystitis acute † 1  2/312 (0.64%)  0/312 (0.00%)  1/310 (0.32%) 
Cholecystitis † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Hepatic mass † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Biliary dilatation † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Infections and infestations       
Pneumonia † 1  9/312 (2.88%)  9/312 (2.88%)  14/310 (4.52%) 
Endophthalmitis † 1  1/312 (0.32%)  4/312 (1.28%)  2/310 (0.65%) 
Sepsis † 1  1/312 (0.32%)  2/312 (0.64%)  2/310 (0.65%) 
Urinary tract infection † 1  1/312 (0.32%)  1/312 (0.32%)  2/310 (0.65%) 
Bronchitis † 1  1/312 (0.32%)  5/312 (1.60%)  1/310 (0.32%) 
Cellulitis † 1  2/312 (0.64%)  0/312 (0.00%)  1/310 (0.32%) 
Device related infection † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Erysipelas † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Febrile infection † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Gastroenteritis viral † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Infective exacerbation of chronic obstructive airways disease † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Pneumonia viral † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Postoperative wound infection † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Tooth infection † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Wound infection † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Diverticulitis † 1  1/312 (0.32%)  1/312 (0.32%)  0/310 (0.00%) 
Appendicitis perforated † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Endocarditis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Gastroenteritis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Herpes zoster † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Influenza † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Localised infection † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Periorbital cellulitis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Peritonsillar abscess † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Pneumonia bacterial † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Pulmonary tuberculosis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Tonsillitis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Septic shock † 1  2/312 (0.64%)  0/312 (0.00%)  0/310 (0.00%) 
Abscess jaw † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Clostridium difficile infection † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Pulmonary sepsis † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Respiratory tract infection † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Retinitis † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Tracheobronchitis † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Urinary tract infection enterococcal † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Injury, poisoning and procedural complications       
Fall † 1  0/312 (0.00%)  1/312 (0.32%)  5/310 (1.61%) 
Hip fracture † 1  1/312 (0.32%)  3/312 (0.96%)  3/310 (0.97%) 
Fractured sacrum † 1  0/312 (0.00%)  1/312 (0.32%)  2/310 (0.65%) 
Ulna fracture † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Upper limb fracture † 1  1/312 (0.32%)  0/312 (0.00%)  1/310 (0.32%) 
Ankle fracture † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Cataract operation complication † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Femur fracture † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Lower limb fracture † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Pelvic fracture † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Pubis fracture † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Rib fracture † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Spinal compression fracture † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Femoral neck fracture † 1  0/312 (0.00%)  3/312 (0.96%)  0/310 (0.00%) 
Meniscus injury † 1  0/312 (0.00%)  2/312 (0.64%)  0/310 (0.00%) 
Radius fracture † 1  0/312 (0.00%)  2/312 (0.64%)  0/310 (0.00%) 
Contusion † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Fibula fracture † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Foot fracture † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Hand fracture † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Inflammation of wound † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Joint injury † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Periprosthetic fracture † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Procedural pneumothorax † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Subdural haemorrhage † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Incisional hernia † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Ocular procedural complication † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Procedural nausea † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Procedural vomiting † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Spinal column injury † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Thermal burn † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Traumatic intracranial haemorrhage † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Investigations       
Heart rate increased † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Intraocular pressure increased † 1  1/312 (0.32%)  1/312 (0.32%)  0/310 (0.00%) 
Blood pressure increased † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Metabolism and nutrition disorders       
Dehydration † 1  1/312 (0.32%)  3/312 (0.96%)  2/310 (0.65%) 
Adult failure to thrive † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Hyperkalaemia † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Hyponatraemia † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Diabetes mellitus inadequate control † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis † 1  2/312 (0.64%)  1/312 (0.32%)  3/310 (0.97%) 
Back pain † 1  0/312 (0.00%)  0/312 (0.00%)  3/310 (0.97%) 
Arthralgia † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Intervertebral disc protrusion † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Dupuytren's contracture † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Lumbar spinal stenosis † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Musculoskeletal chest pain † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Rhabdomyolysis † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Spinal column stenosis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Ankle deformity † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Pain in extremity † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Sacroiliitis † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma † 1  1/312 (0.32%)  0/312 (0.00%)  3/310 (0.97%) 
Renal cancer † 1  0/312 (0.00%)  1/312 (0.32%)  2/310 (0.65%) 
Metastases to bone † 1  1/312 (0.32%)  0/312 (0.00%)  2/310 (0.65%) 
Lung carcinoma cell type unspecified stage IV † 1  0/312 (0.00%)  0/312 (0.00%)  2/310 (0.65%) 
Breast cancer † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Breast cancer metastatic † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Squamous cell carcinoma † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Transitional cell carcinoma † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Adenocarcinoma of colon † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Adenocarcinoma pancreas † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Bone sarcoma † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Breast cancer female † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Clear cell renal cell carcinoma † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Gastric cancer stage IV † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Gastrointestinal carcinoma † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Lung neoplasm malignant † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Oesophageal adenocarcinoma † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Renal neoplasm † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Prostate cancer † 1  0/312 (0.00%)  2/312 (0.64%)  0/310 (0.00%) 
Bladder cancer † 1  1/312 (0.32%)  1/312 (0.32%)  0/310 (0.00%) 
Bowen's disease † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Cholangiocarcinoma † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Gastrointestinal stromal tumour † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Lung adenocarcinoma stage IV † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Malignant melanoma † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Ovarian cancer metastatic † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Plasma cell myeloma † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Small cell lung cancer metastatic † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Squamous cell carcinoma of lung † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Acute myeloid leukaemia † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Benign neoplasm of skin † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Bladder neoplasm † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Bone cancer † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Colon cancer † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Head and neck cancer metastatic † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Lung adenocarcinoma † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Lung cancer metastatic † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Metastases to adrenals † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Renal cell carcinoma † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Spinal cord neoplasm † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Testis cancer † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Tonsil cancer † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Nervous system disorders       
Cerebrovascular accident † 1  2/312 (0.64%)  2/312 (0.64%)  5/310 (1.61%) 
Carotid artery stenosis † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Cognitive disorder † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Haemorrhagic stroke † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Hepatic encephalopathy † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Ischaemic stroke † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Lacunar infarction † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Metabolic encephalopathy † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Polyneuropathy † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Transient ischaemic attack † 1  1/312 (0.32%)  2/312 (0.64%)  0/310 (0.00%) 
Lumbar radiculopathy † 1  1/312 (0.32%)  1/312 (0.32%)  0/310 (0.00%) 
Generalised tonic-clonic seizure † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Quadrantanopia † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Syncope † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Dementia † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Hypoaesthesia † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Myelopathy † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Optic neuritis † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Psychiatric disorders       
Depression † 1  1/312 (0.32%)  0/312 (0.00%)  1/310 (0.32%) 
Suicide attempt † 1  1/312 (0.32%)  0/312 (0.00%)  1/310 (0.32%) 
Intensive care unit delirium † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Completed suicide † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Mental status changes † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Renal and urinary disorders       
Acute kidney injury † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Chronic kidney disease † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Nephritis † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Nephrolithiasis † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Bladder prolapse † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Urinary retention † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia † 1  1/312 (0.32%)  1/312 (0.32%)  1/310 (0.32%) 
Prostatitis † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease † 1  4/312 (1.28%)  1/312 (0.32%)  5/310 (1.61%) 
Pleural effusion † 1  0/312 (0.00%)  0/312 (0.00%)  3/310 (0.97%) 
Dyspnoea † 1  0/312 (0.00%)  0/312 (0.00%)  2/310 (0.65%) 
Pulmonary embolism † 1  0/312 (0.00%)  0/312 (0.00%)  2/310 (0.65%) 
Pulmonary oedema † 1  2/312 (0.64%)  2/312 (0.64%)  1/310 (0.32%) 
Respiratory failure † 1  0/312 (0.00%)  1/312 (0.32%)  1/310 (0.32%) 
Bronchospasm † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Pulmonary mass † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Respiratory disorder † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Bronchopneumopathy † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Pneumonia aspiration † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Pneumothorax † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Pulmonary congestion † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Acute respiratory distress syndrome † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Acute respiratory failure † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Hypoxia † 1  1/312 (0.32%)  0/312 (0.00%)  0/310 (0.00%) 
Skin and subcutaneous tissue disorders       
Panniculitis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Vascular disorders       
Aortic aneurysm † 1  1/312 (0.32%)  2/312 (0.64%)  2/310 (0.65%) 
Aortic stenosis † 1  0/312 (0.00%)  2/312 (0.64%)  1/310 (0.32%) 
Hypertension † 1  2/312 (0.64%)  0/312 (0.00%)  1/310 (0.32%) 
Hypotension † 1  1/312 (0.32%)  0/312 (0.00%)  1/310 (0.32%) 
Deep vein thrombosis † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Peripheral vascular disorder † 1  0/312 (0.00%)  0/312 (0.00%)  1/310 (0.32%) 
Haematoma † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Hypertensive crisis † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
Peripheral ischaemia † 1  0/312 (0.00%)  1/312 (0.32%)  0/310 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abicipar Pegol 2 mg (2Q8) Abicipar Pegol 2 mg (2Q12) Ranibizumab 0.5 mg (rQ4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   202/312 (64.74%)   217/312 (69.55%)   196/310 (63.23%) 
Eye disorders       
Conjunctival haemorrhage † 1  27/312 (8.65%)  32/312 (10.26%)  46/310 (14.84%) 
Neovascular age-related macular degeneration † 1  26/312 (8.33%)  28/312 (8.97%)  39/310 (12.58%) 
Eye pain † 1  26/312 (8.33%)  26/312 (8.33%)  22/310 (7.10%) 
Cataract † 1  29/312 (9.29%)  19/312 (6.09%)  20/310 (6.45%) 
Visual acuity reduced † 1  24/312 (7.69%)  33/312 (10.58%)  18/310 (5.81%) 
Vitreous detachment † 1  19/312 (6.09%)  21/312 (6.73%)  17/310 (5.48%) 
Retinal haemorrhage † 1  16/312 (5.13%)  23/312 (7.37%)  16/310 (5.16%) 
Vitreous floaters † 1  22/312 (7.05%)  20/312 (6.41%)  16/310 (5.16%) 
Eye irritation † 1  11/312 (3.53%)  16/312 (5.13%)  9/310 (2.90%) 
Subretinal fluid † 1  8/312 (2.56%)  17/312 (5.45%)  7/310 (2.26%) 
Iridocyclitis † 1  10/312 (3.21%)  18/312 (5.77%)  2/310 (0.65%) 
Infections and infestations       
Nasopharyngitis † 1  37/312 (11.86%)  36/312 (11.54%)  36/310 (11.61%) 
Urinary tract infection † 1  19/312 (6.09%)  21/312 (6.73%)  31/310 (10.00%) 
Influenza † 1  15/312 (4.81%)  16/312 (5.13%)  24/310 (7.74%) 
Bronchitis † 1  23/312 (7.37%)  19/312 (6.09%)  23/310 (7.42%) 
Conjunctivitis † 1  21/312 (6.73%)  20/312 (6.41%)  11/310 (3.55%) 
Injury, poisoning and procedural complications       
Fall † 1  11/312 (3.53%)  12/312 (3.85%)  17/310 (5.48%) 
Investigations       
Intraocular pressure increased † 1  15/312 (4.81%)  25/312 (8.01%)  13/310 (4.19%) 
Musculoskeletal and connective tissue disorders       
Back pain † 1  14/312 (4.49%)  21/312 (6.73%)  13/310 (4.19%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  14/312 (4.49%)  18/312 (5.77%)  10/310 (3.23%) 
Vascular disorders       
Hypertension † 1  25/312 (8.01%)  20/312 (6.41%)  28/310 (9.03%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan
Phone: 714-246-4500
EMail: IR-CTRegistration@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02462928    
Other Study ID Numbers: 150998-005
2014-004579-22 ( EudraCT Number )
CEDAR ( Other Identifier: Allergan )
First Submitted: June 2, 2015
First Posted: June 4, 2015
Results First Submitted: July 16, 2020
Results First Posted: July 28, 2020
Last Update Posted: July 28, 2020