NCT07215234

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

A Phase 1/2, Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	SAR446597	Intravitreal injection
DRUG	Sham Comparator	Sham injection

Timeline

• Start date: 2025-10-09
• Primary completion: 2027-10-13
• Completion: 2032-07-22
• First posted: 2025-10-10
• Last updated: 2026-03-23

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study