Phase 12 Study of One-time Intravitreal Injection of SAR446597 to Treat Geographic Atrophy Caused by Age-related Macular Degeneration

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a one-time intravitreal injection of SAR446597 in people with Geographic Atrophy GA caused by Age-related Macular Degeneration AMD. This sequential Phase 12 study includes two parts and will take place at multiple centers. The study aims to learn how well this treatment works and how safe it is for participants with this eye condition. Participants will receive a single intravitreal injection of SAR446597, with different dose levels tested across successive groups in Part I. In Part II, participants may receive SAR446597 at one of two dose levels or a sham injection as a control. The core study phase lasts about 2 years per participant, followed by an additional 3-year Extended Follow-Up phase to monitor long-term effects. Throughout the study, participants will undergo regular assessments including eye exams to measure changes in the size of GA lesions and visual acuity using standardized charts. Safety will be monitored closely by tracking any treatment-related adverse events. The total participation time spans approximately 5 years, allowing researchers to evaluate both short- and long-term outcomes of SAR446597 treatment.

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