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Recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT07215234

Public ClinicalTrials.gov record NCT07215234. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 9:24 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT07215234
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Sanofi
Industry
Enrollment
104 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
60 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 9, 2025 (Actual)
Primary completion
Oct 13, 2027 (Estimated)
Completion
Jul 22, 2032 (Estimated)
Last update posted
Oct 20, 2026

2025 – 2032

United States locations

U.S. sites
31
U.S. states
12
U.S. cities
28
Facility City State ZIP Site status
Associated Retina Consultants - Peoria- Site Number : 8400011 Peoria Arizona 85381 Recruiting
Retina Macula Institute of Arizona- Site Number : 8400028 Scottsdale Arizona 85255 Recruiting
Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400033 Beverly Hills California 90211 Recruiting
The Retina Partners- Site Number : 8400040 Encino California 91436 Recruiting
California Retina Consultants - Oxnard - North Ventura Road- Site Number : 8400014 Oxnard California 93036 Recruiting
Retinal Consultants - Sacramento - Parkcenter Drive- Site Number : 8400054 Sacramento California 95825 Recruiting
Macula Retina Vitreous Center - Torrance- Site Number : 8400053 Torrance California 90503 Recruiting
Bay Area Retina Associates - Walnut Creek - Lennon Lane- Site Number : 8400039 Walnut Creek California 94598 Recruiting
Vitreo Retinal Associates - Gainesville- Site Number : 8400004 Gainesville Florida 32607 Recruiting
Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002 St. Petersburg Florida 33711 Recruiting
East Florida Eye Institute- Site Number : 8400038 Stuart Florida 34994 Recruiting
Southeast Retina Center- Site Number : 8400044 Augusta Georgia 30909 Recruiting
University Retina - Lemont- Site Number : 8400005 Lemont Illinois 60439 Recruiting
The Retina Group of Washington - Chevy Chase- Site Number : 8400009 Chevy Chase Maryland 20815 Recruiting
Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 Hagerstown Maryland 21740 Recruiting
Retina Specialist- Site Number : 8400055 Towson Maryland 21204 Recruiting
Sierra Eye Associates- Site Number : 8400021 Reno Nevada 89502 Recruiting
North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400059 Wake Forest North Carolina 27587-3803 Recruiting
Oregon Retina- Site Number : 8400017 Eugene Oregon 97401 Recruiting
Mid Atlantic Retina - Bethlehem- Site Number : 8400031 Bethlehem Pennsylvania 18017-9412 Recruiting
Erie Retina Research- Site Number : 8400035 Erie Pennsylvania 16505 Recruiting
Charleston Neuroscience Institute - Ladson- Site Number : 8400016 Ladson South Carolina 29456 Recruiting
Charleston Neuroscience Institute - Ladson- Site Number : 8400046 Ladson South Carolina 29456 Recruiting
Texas Retina Associates - Arlington- Site Number : 8400056 Arlington Texas 76012 Recruiting
Retina Consultants of Austin- Site Number : 8400015 Austin Texas 78705 Recruiting
Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007 Austin Texas 78750 Recruiting
Retina Consultants of Texas - Bellaire- Site Number : 8400019 Bellaire Texas 77401 Recruiting
Retina Foundation of the Southwest- Site Number : 8400001 Dallas Texas 75231 Recruiting
Texas Retina Associates - Dallas- Site Number : 8400006 Dallas Texas 75231 Recruiting
Retinal Consultants of Texas - San Antonio- Site Number : 8400012 San Antonio Texas 78240 Recruiting
Retina Center of Texas (RCT) - Southlake- Site Number : 8400048 Southlake Texas 76092 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07215234, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 20, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07215234 live on ClinicalTrials.gov.

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