Phase 3
Completed N=286
Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Geographic Atrophy · Dry Age-Related Macular Degeneration
Source: ClinicalTrials.gov NCT02686658 ↗
Enrolled (actual)
286
Serious AEs
22.4%
Results posted
May 2023
Primary outcomePrimary: Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence — 0.292; 0.402; 0.321; 0.444 millimeters (mm) — p=0.0072
◆ Published Evidence
Highly cited
446citations · ~89 / year
C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial.
Summary
The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Linked Publications (3)
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C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial.
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Complement inhibitors for age-related macular degeneration.
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Progression to complete retinal pigment epithelium and outer retinal atrophy (cRORA): post hoc analysis of the GATHER1 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence |
0.292; 0.402; 0.321; 0.444 | 0.0072 sig |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters |
-7.90; -9.29; -3.79; -3.51 | 0.3464 |
| SECONDARY Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters |
-1.03; -1.41; 1.53; 2.97 | 0.8405 |
Eligibility Criteria
Inclusion Criteria
- Participants of either gender aged ≥ 50 years
- Diagnosis of Non-foveal GA secondary to dry AMD
Exclusion Criteria
- Evidence of Choroidal Neovascularization (CNV)
- GA secondary to any condition other than AMD
- Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
- Any intraocular surgery or thermal laser within three (3) months of trial entry
- Any prior thermal laser in the macular region, regardless of indication
- Any ocular or periocular infection in the twelve (12) weeks
- Previous therapeutic radiation in the region of the study eye
- Any sign of diabetic retinopathy in either eye
Data sourced from ClinicalTrials.gov (NCT02686658) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.