Clinical Trial

A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Recruiting Phase 1/2
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Summary
This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). The core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase. The treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).
Protocol Amendment History 1 change
notable Trial sites expanded: 13 -> 17 locations 2026-04-22
Trial Details
NCT Number NCT07215234
Lead Sponsor Sanofi
Conditions Geographic Atrophy
Enrollment 104 participants
Start Date 2025-10-09
Primary Completion 2027-10-13 (estimated)
Study Completion 2032-07-22 (estimated)
Updated on ClinicalTrials.gov 2026-07-01