- 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 I / Phase II • NCT07215234.
- Single eye injection of SAR446597 tested for safety and effectiveness in age-related macular degeneration vision loss over two years.
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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). Conditions: Geographic Atrophy Interventions: SAR446597, Sham Comparator Lead Sponsor: Sanofi Planned Enrollment: 104 participants