Phase 3
Completed N=448
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Geographic Atrophy · Macular Degeneration
Source: ClinicalTrials.gov NCT04435366 ↗
Enrolled (actual)
448
Serious AEs
15.0%
Results posted
Dec 2023
Primary outcomePrimary: The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12 — 0.336; 0.392 millimeters (mm)/year — p=0.0064
◆ Published Evidence
Highly cited
318citations · ~106 / year
Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial.
Summary
The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)
Linked Publications (3)
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Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial.
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Complement inhibitors for age-related macular degeneration.
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Avacincaptad Pegol for Geographic Atrophy Secondary to Age-Related Macular Degeneration: Two-Year Efficacy and Safety Results from the GATHER2 Phase 3 Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12 |
0.336; 0.392 | 0.0064 sig |
| PRIMARY The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24 |
2.23; 2.10; 2.59 | 0.0165 sig |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months |
-7.31; -6.48 | 0.58 |
| SECONDARY Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months |
-10.58; -9.1 | 0.38 |
| SECONDARY Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months |
-1.2; -1.6; -3.4; -3.6; -5.4; -4.7 | — |
| SECONDARY Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months |
-7.735; -7.023 | 0.5929 |
| SECONDARY Number of Participants With Categorical One-level Loss in VFQ-25 Subscale |
45; 35; 56; 43; 61; 49 | — |
| SECONDARY Time to Persistent Vision Loss |
17.02; 13.93 | 0.6424 |
Eligibility Criteria
Inclusion Criteria
- Subjects of either gender aged ≥ 50 years
- Diagnosis of Non-foveal GA secondary to dry AMD
Exclusion Criteria
- Any prior treatment for AMD (dry or wet) 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 3 months of trial entry.
- Any prior thermal laser in the macular region, regardless of indication
- Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 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 (NCT04435366) 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.