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NCT07215234PHASE1, PHASE2Recruiting

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

Sanofi

Start Date

10/9/2025

Completion Date

7/22/2032

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 Criteria

Age Range: 60 years to No maximum

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: * GA in the study eye caused by a disease different than AMD * Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye * Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments * Current or history of systemic complement targeting treatment in the past 12 months * Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye * History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye * History of active ocular infection in the study eye in 6 months prior to screening * Presence of active ocular or periocular infections * Active uncontrolled glaucoma in the study eye * History of uveitis or scleritis in either eye * Previous gene therapy in either eye * Any significant poorly controlled illness that would preclude study compliance and follow up The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Interventions

DRUG

SAR446597

DRUG

Sham Comparator

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Conditions

Geographic Atrophy

Locations

Associated Retina Consultants - Peoria- Site Number : 8400011

Peoria, Arizona 85381

United States

Retina Macula Institute of Arizona- Site Number : 8400028

Scottsdale, Arizona 85255

United States

Vitreo Retinal Associates - Gainesville- Site Number : 8400004

Gainesville, Florida 32607

United States

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

St. Petersburg, Florida 33711

United States

University Retina - Lemont- Site Number : 8400005

Lemont, Illinois 60439

United States

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

Chevy Chase, Maryland 20815

United States

Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003

Hagerstown, Maryland 21740

United States

Oregon Retina- Site Number : 8400017

Eugene, Oregon 97401

United States

Mid Atlantic Retina - Bethlehem- Site Number : 8400031

Bethlehem, Pennsylvania 18017-9412

United States

Retina Consultants of Austin- Site Number : 8400015

Austin, Texas 78705

United States

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

Austin, Texas 78750

United States

Retina Consultants of Texas - Bellaire- Site Number : 8400019

Bellaire, Texas 77401

United States

Retina Foundation of the Southwest- Site Number : 8400001

Dallas, Texas 75231

United States

Texas Retina Associates - Dallas- Site Number : 8400006

Dallas, Texas 75231

United States

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

San Antonio, Texas 78240

United States

Investigational Site Number : 0360003

Sydney, New South Wales 2000

Australia

Investigational Site Number : 0360002

Adelaide, South Australia 5000

Australia

Investigational Site Number : 0360001

East Melbourne, Victoria 3002

Australia