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Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT02686658
Recruitment Status : Completed
First Posted : February 19, 2016
Results First Posted : May 11, 2023
Last Update Posted : February 23, 2024
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( IVERIC bio, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Geographic Atrophy
Macular Degeneration
Interventions Drug: Zimura
Other: Sham
Enrollment 286
Recruitment Details  
Pre-assignment Details Study participants are planned to receive 18 monthly intravitreal injections of Zimura and/or Sham in a single designated study eye. The study eye is designated by the Investigator prior to first administration of study drug and does not change throughout the duration of study participation.
Arm/Group Title Zimura 1 mg [Part 1] Zimura 2 mg [Part 1] Sham [Part 1] Zimura 2 mg (Zimura 2mg+Sham) [Part 2] Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2] Sham (Sham+Sham) [Part 2]
Hide Arm/Group Description Participants received 1 mg of Zimura in the study eye administered via intravitreal (IVT) injection on Day 1 and monthly up to 18 months. Participants received 2 mg of Zimura in the study eye administered via IVT injection on Day 1 and monthly up to 18 months. Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months. Participants received 2 mg of Zimura in the study eye administered via IVT injection and a Sham administration on Day 1 and monthly up to 18 months. Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months. Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
Period Title: Overall Study
Started 26 25 26 42 83 84
Month 12 23 19 19 34 56 72
Completed 22 18 17 30 46 68
Not Completed 4 7 9 12 37 16
Reason Not Completed
Adverse Event             0             0             1             1             2             1
Investigator decision             0             0             0             1             2             1
Sponsor decision             1             2             1             5             13             2
Lost to Follow-up             0             0             2             0             0             1
Death             1             0             0             1             1             1
Withdrawal by Subject             2             5             4             4             17             8
Placed in hospice care             0             0             1             0             0             0
Participant non-compliance             0             0             0             0             0             1
Concern over coronavirus disease care             0             0             0             0             2             1
Arm/Group Title Zimura 1 mg [Part 1] Zimura 2 mg [Part 1] Sham [Part 1] Zimura 2 mg (Zimura 2mg+Sham) [Part 2] Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2] Sham (Sham+Sham) [Part 2] Total
Hide Arm/Group Description Participants received 1 mg of Zimura in the study eye administered via intravitreal (IVT) injection on Day 1 and monthly up to 18 months. Participants received 2 mg of Zimura in the study eye administered via IVT injection on Day 1 and monthly up to 18 months. Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months. Participants received 2 mg of Zimura in the study eye administered via IVT injection and a Sham administration on Day 1 and monthly up to 18 months. Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months. Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months. Total of all reporting groups
Overall Number of Baseline Participants 26 25 26 42 83 84 286
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 26 participants 42 participants 83 participants 84 participants 286 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  11.5%
4
  16.0%
2
   7.7%
6
  14.3%
5
   6.0%
4
   4.8%
24
   8.4%
>=65 years
23
  88.5%
21
  84.0%
24
  92.3%
36
  85.7%
78
  94.0%
80
  95.2%
262
  91.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 26 participants 42 participants 83 participants 84 participants 286 participants
Female
15
  57.7%
18
  72.0%
18
  69.2%
27
  64.3%
58
  69.9%
61
  72.6%
197
  68.9%
Male
11
  42.3%
7
  28.0%
8
  30.8%
15
  35.7%
25
  30.1%
23
  27.4%
89
  31.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 26 participants 42 participants 83 participants 84 participants 286 participants
Hispanic or Latino
1
   3.8%
1
   4.0%
1
   3.8%
0
   0.0%
1
   1.2%
1
   1.2%
5
   1.7%
Not Hispanic or Latino
25
  96.2%
24
  96.0%
25
  96.2%
42
 100.0%
82
  98.8%
83
  98.8%
281
  98.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 26 participants 42 participants 83 participants 84 participants 286 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.2%
1
   0.3%
White
25
  96.2%
25
 100.0%
25
  96.2%
42
 100.0%
82
  98.8%
82
  97.6%
281
  98.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   3.8%
0
   0.0%
1
   1.2%
1
   1.2%
3
   1.0%
1.Primary Outcome
Title Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence
Hide Description The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was conducted in 2 Parts. The analyses were based on comparisons of Zimura 2mg vs. Sham control and Zimura 4mg vs. Sham control. For comparison of Zimura 2mg vs. Sham control, participants randomized in Part 1 were combined with participants randomized in Part 2. Comparison of Zimura 4mg vs. Sham control was based on participants randomized in Part 2 only.
Arm/Group Title Zimura 2 mg [Part 1 & Part 2 Combined] Sham [Part 1 & Part 2 Combined] Zimura 4 mg [Part 2] Sham [Part 2]
Hide Arm/Group Description:
Participants received 2 mg of Zimura in the study eye administered via IVT injection (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.
Participants received a Sham injection (or 2 Sham injections) of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.
Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
Overall Number of Participants Analyzed 67 110 83 84
Least Squares Mean (Standard Error)
Unit of Measure: millimeters (mm)
0.292  (0.077) 0.402  (0.075) 0.321  (0.074) 0.444  (0.072)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zimura 2 mg [Part 1 & Part 2 Combined], Sham [Part 1 & Part 2 Combined]
Comments Difference in least squares means between groups calculated as (Sham) minus (Zimura).
Type of Statistical Test Other
Comments Model for repeated measures (MRM) and square root transformation was used to compare the treatment groups.
Statistical Test of Hypothesis P-Value 0.0072
Comments [Not Specified]
Method Model for repeated measures (MRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.110
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zimura 4 mg [Part 2], Sham [Part 2]
Comments Difference in least squares means between groups calculated as (Sham) minus (Zimura).
Type of Statistical Test Other
Comments Model for repeated measures (MRM) and square root transformation was used to compare treatment groups.
Statistical Test of Hypothesis P-Value 0.0051
Comments [Not Specified]
Method Model for repeated measures (MRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.124
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters
Hide Description The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study [ETDRS] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was conducted in 2 Parts. The analyses were based on comparisons of Zimura 2mg vs. Sham control and Zimura 4mg vs. Sham control. For comparison of Zimura 2mg vs. Sham control, participants randomized in Part 1 were combined with participants randomized in Part 2. Comparison of Zimura 4mg vs. Sham control was based on participants randomized in Part 2 only.
Arm/Group Title Zimura 2 mg [Part 1 & Part 2 Combined] Sham [Part 1 & Part 2 Combined] Zimura 4 mg [Part 2] Sham [Part 2]
Hide Arm/Group Description:
Participants received 2 mg of Zimura in the study eye administered via IVT injection (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.
Participants received a Sham injection (or 2 Sham injections) of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.
Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
Overall Number of Participants Analyzed 67 110 83 84
Least Squares Mean (Standard Error)
Unit of Measure: ETDRS Letters
-7.90  (2.66) -9.29  (2.59) -3.79  (3.11) -3.51  (2.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zimura 2 mg [Part 1 & Part 2 Combined], Sham [Part 1 & Part 2 Combined]
Comments Difference in least squares mean between groups calculated as (Zimura) minus (Sham).
Type of Statistical Test Other
Comments Model for repeated measures (MRM) was used to compare the treatment groups.
Statistical Test of Hypothesis P-Value 0.3464
Comments [Not Specified]
Method Model for repeated measures (MRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zimura 4 mg [Part 2], Sham [Part 2]
Comments Difference in least squares mean between groups calculated as (Zimura) minus (Sham).
Type of Statistical Test Other
Comments Model for repeated measures (MRM) was used to compare the treatment groups.
Statistical Test of Hypothesis P-Value 0.8830
Comments [Not Specified]
Method Model for repeated measures (MRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.28
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters
Hide Description The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was conducted in 2 Parts. The analyses were based on comparisons of Zimura 2mg vs. Sham control and Zimura 4mg vs. Sham control. For comparison of Zimura 2mg vs. Sham control, participants randomized in Part 1 were combined with participants randomized in Part 2. Comparison of Zimura 4mg vs. Sham control was based on participants randomized in Part 2 only.
Arm/Group Title Zimura 2 mg [Part 1 & Part 2 Combined] Sham [Part 1 & Part 2 Combined] Zimura 4 mg [Part 2] Sham [Part 2]
Hide Arm/Group Description:
Participants received 2 mg of Zimura in the study eye administered via IVT injection (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.
Participants received a Sham injection (or 2 Sham injections) of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.
Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
Overall Number of Participants Analyzed 67 110 83 84
Least Squares Mean (Standard Error)
Unit of Measure: ETDRS Letters
-1.03  (3.40) -1.41  (3.30) 1.53  (3.53) 2.97  (3.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zimura 2 mg [Part 1 & Part 2 Combined], Sham [Part 1 & Part 2 Combined]
Comments Difference in least squares mean between groups calculated as (Zimura) minus (Sham).
Type of Statistical Test Other
Comments Model for repeated measures (MRM) was used to compare the treatment groups.
Statistical Test of Hypothesis P-Value 0.8405
Comments [Not Specified]
Method Model for repeated measures (MRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zimura 4 mg [Part 2], Sham [Part 2]
Comments Difference in least squares mean between groups calculated as (Zimura) minus (Sham).
Type of Statistical Test Other
Comments Model for repeated measures (MRM) was used to compare the treatment groups.
Statistical Test of Hypothesis P-Value 0.5017
Comments [Not Specified]
Method Model for repeated measures (MRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.44
Estimation Comments [Not Specified]
Time Frame Adverse events were recorded starting at Day 1 after the first dose of study drug and continuing until 30 days after the last dose or until the last follow-up visit required by the protocol, whichever comes later (up to approximately 18 months from first dose).
Adverse Event Reporting Description The analysis population for all-cause mortality, serious adverse events (SAEs), and non-serious adverse events (NSAEs) consisted of all participants who received at least one dose of study treatment. Participants who received an injection of Zimura during this study were analyzed in the appropriate Zimura group according to the actual injections received.
 
Arm/Group Title Zimura 1 mg [Part 1] Zimura 2 mg [Part 1] Sham [Part 1] Zimura 2 mg (Zimura 2mg+Sham) [Part 2] Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2] Sham (Sham+Sham) [Part 2] Zimura (Any Dose) [Part 1 & Part 2 Combined] Sham [Part 1 & Part 2 Combined]
Hide Arm/Group Description Participants received 1 mg of Zimura in the study eye administered via intravitreal (IVT) injection on Day 1 and monthly up to 18 months. Participants received 2 mg of Zimura in the study eye administered via IVT injection on Day 1 and monthly up to 18 months. Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months. Participants received 2 mg of Zimura in the study eye administered via IVT injection and a Sham administration on Day 1 and monthly up to 18 months. Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months. Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months. Participants received a 1 mg, 2 mg, or 4 mg dose of Zimura in the study eye administered via 1 or 2 IVT injection(s) (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months. Participants received a Sham injection (or 2 Sham injections) of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
All-Cause Mortality
Zimura 1 mg [Part 1] Zimura 2 mg [Part 1] Sham [Part 1] Zimura 2 mg (Zimura 2mg+Sham) [Part 2] Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2] Sham (Sham+Sham) [Part 2] Zimura (Any Dose) [Part 1 & Part 2 Combined] Sham [Part 1 & Part 2 Combined]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/26 (3.85%)   0/25 (0.00%)   0/26 (0.00%)   1/42 (2.38%)   1/83 (1.20%)   1/84 (1.19%)   3/176 (1.70%)   1/110 (0.91%) 
Hide Serious Adverse Events
Zimura 1 mg [Part 1] Zimura 2 mg [Part 1] Sham [Part 1] Zimura 2 mg (Zimura 2mg+Sham) [Part 2] Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2] Sham (Sham+Sham) [Part 2] Zimura (Any Dose) [Part 1 & Part 2 Combined] Sham [Part 1 & Part 2 Combined]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/26 (11.54%)   4/25 (16.00%)   7/26 (26.92%)   8/42 (19.05%)   21/83 (25.30%)   21/84 (25.00%)   36/176 (20.45%)   28/110 (25.45%) 
Blood and lymphatic system disorders                 
Iron deficiency anemia † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Cardiac disorders                 
Acute myocardial infarction † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/42 (2.38%)  1/83 (1.20%)  0/84 (0.00%)  2/176 (1.14%)  0/110 (0.00%) 
Mitral valve stenosis † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Ventricular extrasystoles † 1  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Cardiac failure congestive † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Coronary artery disease † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  2/84 (2.38%)  0/176 (0.00%)  3/110 (2.73%) 
Eye disorders                 
Optic ischaemic neuropathy* † 1 [1]  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/42 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Retinal detachment* † 1 [1]  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Gastrointestinal disorders                 
Colitis † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Gastrointestinal necrosis † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Lower gastrointestinal haemorrhage † 1  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Upper gastrointestinal haemorrhage † 1  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Abdominal hernia † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/176 (0.00%)  1/110 (0.91%) 
Appendiceal mucocoele † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Diarrhoea † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Faecaloma † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Gastrointestinal haemorrhage † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Gastrooesophageal reflux disease † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Large intestinal stenosis † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/176 (0.00%)  1/110 (0.91%) 
Small intestinal obstruction † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
General disorders                 
Asthenia † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/42 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Non-cardiac chest pain † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/42 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Hepatobiliary disorders                 
Bile duct stone † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Cholelithiasis † 1  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Cholecystitis † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/176 (0.00%)  1/110 (0.91%) 
Infections and infestations                 
Pneumonia † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/42 (2.38%)  3/83 (3.61%)  1/84 (1.19%)  4/176 (2.27%)  1/110 (0.91%) 
Cellulitis † 1  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/42 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  2/176 (1.14%)  0/110 (0.00%) 
Sepsis † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  2/83 (2.41%)  0/84 (0.00%)  2/176 (1.14%)  0/110 (0.00%) 
Cystitis † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Diverticulitis † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Escherichia urinary tract infection † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Groin abscess † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Urosepsis † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Urinary tract infection † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  2/84 (2.38%)  0/176 (0.00%)  2/110 (1.82%) 
Injury, poisoning and procedural complications                 
Femur fracture † 1  0/26 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  2/176 (1.14%)  1/110 (0.91%) 
Fall † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  1/42 (2.38%)  0/83 (0.00%)  1/84 (1.19%)  1/176 (0.57%)  2/110 (1.82%) 
Hip fracture † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Rib fracture † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Road traffic accident † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Ulna fracture † 1  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Head injury † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Upper limb fracture † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Metabolism and nutrition disorders                 
Hyperglycaemia † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/176 (0.00%)  1/110 (0.91%) 
Hyponatraemia † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/176 (0.00%)  1/110 (0.91%) 
Musculoskeletal and connective tissue disorders                 
Intervertebral disc protrusion † 1  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Lumbar spinal stenosis † 1  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  1/176 (0.57%)  1/110 (0.91%) 
Back pain † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Osteoarthritis † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Bladder cancer † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/42 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Metastases to bone † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Prostate cancer stage IV † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Breast cancer † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Lung cancer metastatic † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Lung neoplasm malignant † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Metastases to adrenals † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Metastases to central nervous system † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Pancreatic carcinoma metastatic † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/176 (0.00%)  1/110 (0.91%) 
Nervous system disorders                 
Cerebrovascular accident † 1  1/26 (3.85%)  1/25 (4.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  1/84 (1.19%)  3/176 (1.70%)  1/110 (0.91%) 
Cerebral infarction † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/42 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Dizziness † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Ischaemic cerebral infarction † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Syncope † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/42 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  1/176 (0.57%)  0/110 (0.00%) 
Cerebral haemorrhage † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Ischaemic stroke † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/176 (0.00%)  1/110 (0.91%) 
Lumbar radiculopathy † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/176 (0.00%)  1/110 (0.91%) 
Psychiatric disorders                 
Anxiety † 1  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/176 (0.00%)  1/110 (0.91%) 
Hallucination † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Respiratory, thoracic and mediastinal disorders                 
Chronic obstructive pulmonary disease † 1  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  3/84 (3.57%)  2/176 (1.14%)  3/110 (2.73%) 
Pneumonia aspiration † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  1/83 (1.20%)  1/84 (1.19%)  1/176 (0.57%)  1/110 (0.91%) 
Pneumothorax † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Respiratory distress † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
Vascular disorders                 
Subclavian artery stenosis † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/176 (0.00%)  1/110 (0.91%) 
1
Term from vocabulary, MedDRA 18.1
†
Indicates events were collected by systematic assessment
[1]
* included study and fellow eye events
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zimura 1 mg [Part 1] Zimura 2 mg [Part 1] Sham [Part 1] Zimura 2 mg (Zimura 2mg+Sham) [Part 2] Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2] Sham (Sham+Sham) [Part 2] Zimura (Any Dose) [Part 1 & Part 2 Combined] Sham [Part 1 & Part 2 Combined]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/26 (50.00%)   13/25 (52.00%)   10/26 (38.46%)   34/42 (80.95%)   66/83 (79.52%)   49/84 (58.33%)   126/176 (71.59%)   59/110 (53.64%) 
Eye disorders                 
Conjunctival haemorrhage * † 1 [1]  2/26 (7.69%)  2/25 (8.00%)  1/26 (3.85%)  9/42 (21.43%)  28/83 (33.73%)  12/84 (14.29%)  41/176 (23.30%)  13/110 (11.82%) 
Neovascular age-related macular degeneration* † 1 [1]  3/26 (11.54%)  2/25 (8.00%)  2/26 (7.69%)  7/42 (16.67%)  11/83 (13.25%)  2/84 (2.38%)  23/176 (13.07%)  4/110 (3.64%) 
Conjunctival hyperaemia* † 1 [1]  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  3/42 (7.14%)  9/83 (10.84%)  4/84 (4.76%)  12/176 (6.82%)  4/110 (3.64%) 
Punctate keratitis* † 1 [1]  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  4/42 (9.52%)  6/83 (7.23%)  8/84 (9.52%)  10/176 (5.68%)  8/110 (7.27%) 
Eye pain* † 1 [1]  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/42 (2.38%)  8/83 (9.64%)  3/84 (3.57%)  10/176 (5.68%)  3/110 (2.73%) 
Vitreous detachment* † 1 [1]  3/26 (11.54%)  0/25 (0.00%)  0/26 (0.00%)  2/42 (4.76%)  4/83 (4.82%)  6/84 (7.14%)  9/176 (5.11%)  6/110 (5.45%) 
Cataract* † 1 [1]  2/26 (7.69%)  0/25 (0.00%)  1/26 (3.85%)  4/42 (9.52%)  2/83 (2.41%)  5/84 (5.95%)  8/176 (4.55%)  6/110 (5.45%) 
Visual acuity reduced* † 1 [1]  0/26 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  2/42 (4.76%)  3/83 (3.61%)  8/84 (9.52%)  7/176 (3.98%)  8/110 (7.27%) 
Conjunctival oedema* † 1 [1]  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/42 (4.76%)  5/83 (6.02%)  4/84 (4.76%)  7/176 (3.98%)  4/110 (3.64%) 
Choroidal neovascularization* † 1 [1]  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/42 (0.00%)  5/83 (6.02%)  3/84 (3.57%)  6/176 (3.41%)  3/110 (2.73%) 
Eye irritation* † 1 [1]  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  3/42 (7.14%)  2/83 (2.41%)  4/84 (4.76%)  5/176 (2.84%)  5/110 (4.55%) 
Posterior capsule opacification* † 1 [1]  0/26 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  0/42 (0.00%)  0/83 (0.00%)  2/84 (2.38%)  2/176 (1.14%)  2/110 (1.82%) 
Infections and infestations                 
Urinary tract infection † 1  2/26 (7.69%)  0/25 (0.00%)  2/26 (7.69%)  7/42 (16.67%)  10/83 (12.05%)  8/84 (9.52%)  19/176 (10.80%)  10/110 (9.09%) 
Nasopharyngitis † 1  1/26 (3.85%)  3/25 (12.00%)  0/26 (0.00%)  4/42 (9.52%)  3/83 (3.61%)  5/84 (5.95%)  11/176 (6.25%)  5/110 (4.55%) 
Sinusitis † 1  2/26 (7.69%)  1/25 (4.00%)  0/26 (0.00%)  2/42 (4.76%)  3/83 (3.61%)  3/84 (3.57%)  8/176 (4.55%)  3/110 (2.73%) 
Upper respiratory tract infection † 1  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  2/42 (4.76%)  5/83 (6.02%)  2/84 (2.38%)  8/176 (4.55%)  2/110 (1.82%) 
Influenza † 1  0/26 (0.00%)  2/25 (8.00%)  1/26 (3.85%)  1/42 (2.38%)  0/83 (0.00%)  1/84 (1.19%)  3/176 (1.70%)  2/110 (1.82%) 
Rhinitis † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  3/42 (7.14%)  0/83 (0.00%)  2/84 (2.38%)  3/176 (1.70%)  2/110 (1.82%) 
Injury, poisoning and procedural complications                 
Fall † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  8/42 (19.05%)  6/83 (7.23%)  7/84 (8.33%)  14/176 (7.95%)  7/110 (6.36%) 
Laceration † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  3/42 (7.14%)  0/83 (0.00%)  3/84 (3.57%)  3/176 (1.70%)  3/110 (2.73%) 
Contusion † 1  0/26 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  1/42 (2.38%)  2/83 (2.41%)  0/84 (0.00%)  3/176 (1.70%)  2/110 (1.82%) 
Investigations                 
Intraocular pressure increased † 1  1/26 (3.85%)  2/25 (8.00%)  0/26 (0.00%)  4/42 (9.52%)  19/83 (22.89%)  1/84 (1.19%)  26/176 (14.77%)  1/110 (0.91%) 
Metabolism and nutrition disorders                 
Hypokalaemia † 1  0/26 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  0/42 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/176 (0.57%)  2/110 (1.82%) 
Musculoskeletal and connective tissue disorders                 
Osteoarthritis † 1  2/26 (7.69%)  0/25 (0.00%)  0/26 (0.00%)  1/42 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  3/176 (1.70%)  0/110 (0.00%) 
Spinal column stenosis † 1  2/26 (7.69%)  0/25 (0.00%)  1/26 (3.85%)  0/42 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  2/176 (1.14%)  2/110 (1.82%) 
Nervous system disorders                 
Dementia † 1  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  3/42 (7.14%)  0/83 (0.00%)  0/84 (0.00%)  3/176 (1.70%)  0/110 (0.00%) 
Vascular disorders                 
Hypertension † 1  0/26 (0.00%)  1/25 (4.00%)  2/26 (7.69%)  0/42 (0.00%)  3/83 (3.61%)  2/84 (2.38%)  4/176 (2.27%)  4/110 (3.64%) 
1
Term from vocabulary, MedDRA 18.1
†
Indicates events were collected by systematic assessment
[1]
* included study and fellow eye events
[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.
No individual site or investigator may publish or present any results from the trial until a joint, multi-center publication of the trial results is made by Sponsor in conjunction with various participating investigators and appropriate sites contributing data and comments. Subsequently, individual investigators may request to publish or present results from the trial; however approval will be at the sole discretion of the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: IVERIC Bio, Inc.
Phone: 609-474-6755
EMail: info@ivericbio.com
Publications of Results:
Jaffe GJ, Westby K, Csaky KG, Mones J, Pearlman JA, Patel SS, Joondeph BC, Randolph J, Masonson H, Rezaei KA. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021 Apr;128(4):576-586. doi: 10.1016/j.ophtha.2020.08.027. Epub 2020 Sep 1.
Layout table for additonal information
Responsible Party: Astellas Pharma Inc ( IVERIC bio, Inc. )
ClinicalTrials.gov Identifier: NCT02686658    
Other Study ID Numbers: OPH2003
2015-003991-56 ( EudraCT Number )
First Submitted: February 16, 2016
First Posted: February 19, 2016
Results First Submitted: January 27, 2023
Results First Posted: May 11, 2023
Last Update Posted: February 23, 2024