The Phase 3 long-term extension study (NCT04770545) evaluating pegcetacoplan for geographic atrophy secondary to age-related macular degeneration (AMD) completed its primary phase on 2025-09-05. This open-label, multicenter study aimed to assess the long-term safety and efficacy of the drug in previously enrolled subjects.
Background
Pegcetacoplan (APL-2) is an investigational drug for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). GA is an advanced form of AMD, a leading cause of irreversible vision loss in older adults.
Trial design
The extension study, identified as NCT04770545, is a Phase 3, open-label, multicenter trial. It enrolled 792 participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study evaluated the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects who had previously participated in Study APL2-103 (NCT03777332) or completed treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600).
What this means
The primary completion of this Phase 3 extension study marks a significant step in the long-term evaluation of pegcetacoplan for geographic atrophy secondary to AMD. The study's focus on long-term safety and efficacy is crucial for understanding the potential sustained benefits and risks of the treatment. Data from this completed phase will contribute to the comprehensive understanding of pegcetacoplan's profile.
Source
The information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04770545, titled "An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD," was updated on 2025-09-05 on clinicaltrials.gov.