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Clinical Trials in the USA / NCT07215234
Recruiting Phase 1/2

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

NCT07215234 · tracked via the Priya Life Science USA tracker
Sponsor
Sanofi
Phase
Phase 1/2
Started
2025-10-09
Last updated
2026-09-18

Condition(s) studied

Geographic Atrophy

Investigational drug(s) / intervention(s)

SAR446597Sham Comparator

SAR446597: Intravitreal injection

Sham Comparator: Sham injection

Study 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

Sex
ALL
Min age
60 Years
Max age
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: * 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.

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Associated Retina Consultants - Peoria- Site Number : 8400011 Peoria Arizona Recruiting
Retina Macula Institute of Arizona- Site Number : 8400028 Scottsdale Arizona Recruiting
Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400033 Beverly Hills California Recruiting
Retinal Consultants - Sacramento - Parkcenter Drive- Site Number : 8400054 Sacramento California Recruiting
Macula Retina Vitreous Center - Torrance- Site Number : 8400053 Torrance California Recruiting
Vitreo Retinal Associates - Gainesville- Site Number : 8400004 Gainesville Florida Recruiting
Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002 St. Petersburg Florida Recruiting
Southeast Retina Center- Site Number : 8400044 Augusta Georgia Recruiting
University Retina - Lemont- Site Number : 8400005 Lemont Illinois Recruiting
The Retina Group of Washington - Chevy Chase- Site Number : 8400009 Chevy Chase Maryland Recruiting
Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 Hagerstown Maryland Recruiting
Retina Specialist- Site Number : 8400055 Towson Maryland Recruiting
Sierra Eye Associates- Site Number : 8400021 Reno Nevada Recruiting
North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400059 Wake Forest North Carolina Recruiting
Oregon Retina- Site Number : 8400017 Eugene Oregon Recruiting
Mid Atlantic Retina - Bethlehem- Site Number : 8400031 Bethlehem Pennsylvania Recruiting
Erie Retina Research- Site Number : 8400035 Erie Pennsylvania Recruiting
Charleston Neuroscience Institute - Ladson- Site Number : 8400016 Ladson South Carolina Recruiting
Charleston Neuroscience Institute - Ladson- Site Number : 8400046 Ladson South Carolina Recruiting
Texas Retina Associates - Arlington- Site Number : 8400056 Arlington Texas Recruiting
Retina Consultants of Austin- Site Number : 8400015 Austin Texas Recruiting
Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007 Austin Texas Recruiting
Retina Consultants of Texas - Bellaire- Site Number : 8400019 Bellaire Texas Recruiting
Retina Foundation of the Southwest- Site Number : 8400001 Dallas Texas Recruiting
Texas Retina Associates - Dallas- Site Number : 8400006 Dallas Texas Recruiting
Retinal Consultants of Texas - San Antonio- Site Number : 8400012 San Antonio Texas Recruiting
Retina Center of Texas (RCT) - Southlake- Site Number : 8400048 Southlake Texas Recruiting
Investigational Site Number : 0360003 Sydney New South Wales Recruiting
Investigational Site Number : 0360002 Adelaide South Australia Recruiting
Investigational Site Number : 0360001 East Melbourne Victoria Recruiting

More Sanofi trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07215234 on ClinicalTrials.gov ↗ ← All trials in the USA