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
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Associated Retina Consultants - Peoria - DocTrials - PPDS- Site Number : 8400011
RECRUITING
Peoria
Retina Macula Institute of Arizona- Site Number : 8400028
RECRUITING
Scottsdale
Florida
Vitreo Retinal Associates - Gainesville- Site Number : 8400004
RECRUITING
Gainesville
Illinois
University Retina - Lemont- Site Number : 8400005
RECRUITING
Lemont
Oregon
Oregon Retina- Site Number : 8400017
RECRUITING
Eugene
Texas
Retina Foundation of the Southwest- Site Number : 8400001
RECRUITING
Dallas
Texas Retina Associates - Dallas- Site Number : 8400006
RECRUITING
Dallas
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date:2025-10-09
Estimated Completion Date:2032-07-22
Participants
Target number of participants:104
Treatments
Experimental: Part I - SAR446597 open-label (OL)
Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.
Experimental: Part II - SAR446597 Dose A
Participants will receive SAR at a dose specified for each arm.
Experimental: Part II - SAR446597 Dose B
Participants will receive SAR at a dose specified for each arm.
Sham_comparator: Part II - Sham control
Participants will receive Sham at a dose specified for each arm.