RecruitingPhase 1Phase 2NCT07215234

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

Sponsor

Sanofi

Enrollment

104 participants

Start Date

Oct 9, 2025

Study Type

INTERVENTIONAL

Conditions

Geographic Atrophy

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SAR446597 and a drug called Sham Comparator for people with geographic atrophy. The study is currently recruiting participants at 18 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSAR446597

Intravitreal injection

DRUGSham Comparator

Sham injection

Locations(18)

Associated Retina Consultants - Peoria- Site Number : 8400011

Peoria, Arizona, United States

Retina Macula Institute of Arizona- Site Number : 8400028

Scottsdale, Arizona, United States

Vitreo Retinal Associates - Gainesville- Site Number : 8400004

Gainesville, Florida, United States

Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002

St. Petersburg, Florida, United States

University Retina - Lemont- Site Number : 8400005

Lemont, Illinois, United States

The Retina Group of Washington - Chevy Chase- Site Number : 8400009

Chevy Chase, Maryland, United States

Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003

Hagerstown, Maryland, United States

Oregon Retina- Site Number : 8400017

Eugene, Oregon, United States

Mid Atlantic Retina - Bethlehem- Site Number : 8400031

Bethlehem, Pennsylvania, United States

Retina Consultants of Austin- Site Number : 8400015

Austin, Texas, United States

Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007

Austin, Texas, United States

Retina Consultants of Texas - Bellaire- Site Number : 8400019

Bellaire, Texas, United States

Retina Foundation of the Southwest- Site Number : 8400001

Dallas, Texas, United States

Texas Retina Associates - Dallas- Site Number : 8400006

Dallas, Texas, United States

Retinal Consultants of Texas - San Antonio- Site Number : 8400012

San Antonio, Texas, United States

Investigational Site Number : 0360003

Sydney, New South Wales, Australia

Investigational Site Number : 0360002

Adelaide, South Australia, Australia

Investigational Site Number : 0360001

East Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT07215234

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