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
Sanofi
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).
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 60 years old or above * Participants with diagnosis of GA secondary to age-related macular degeneration (AMD) * Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200 * Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II Exclusion Criteria…
Interventions
- DrugSAR446597
Intravitreal injection
- DrugSham Comparator
Sham injection
Locations (17)
- Associated Retina Consultants - Peoria- Site Number : 8400011Peoria, Arizona
- Retina Macula Institute of Arizona- Site Number : 8400028Scottsdale, Arizona
- Vitreo Retinal Associates - Gainesville- Site Number : 8400004Gainesville, Florida
- Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002St. Petersburg, Florida
- University Retina - Lemont- Site Number : 8400005Lemont, Illinois
- The Retina Group of Washington - Chevy Chase- Site Number : 8400009Chevy Chase, Maryland