Recruiting
Phase 1
Phase 2

SAR446597

Sponsor:

Sanofi

Code:

NCT07215234

Conditions

Geographic Atrophy

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

SAR446597

Sham Comparator

Study Details

Brief 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).

Conditions

Geographic Atrophy

Study ID

NCT07215234

Start date

Oct 9, 2025

Status verified date

Oct, 2026

Completion date

Jul 22, 2032

Anticipated

Primary completion date

Oct 13, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

SAR446597

Intravitreal injection

Sham Comparator

Sham injection

Primary outcome measure

  • Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 to Week 104 ]
  • Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs) [ Time Frame: Day 1 to Week 104 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

Associated Retina Consultants - Peoria- Site Number : 8400011

Recruiting

Peoria, Arizona, United States, 85381

Retina Macula Institute of Arizona- Site Number : 8400028

Recruiting

Scottsdale, Arizona, United States, 85255

Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400033

Recruiting

Beverly Hills, California, United States, 90211

The Retina Partners- Site Number : 8400040

Recruiting

Encino, California, United States, 91436

California Retina Consultants - Oxnard - North Ventura Road- Site Number : 8400014

Recruiting

Oxnard, California, United States, 93036

Retinal Consultants - Sacramento - Parkcenter Drive- Site Number : 8400054

Recruiting

Sacramento, California, United States, 95825

Macula Retina Vitreous Center - Torrance- Site Number : 8400053

Recruiting

Torrance, California, United States, 90503

Bay Area Retina Associates - Walnut Creek - Lennon Lane- Site Number : 8400039

Recruiting

Walnut Creek, California, United States, 94598

Vitreo Retinal Associates - Gainesville- Site Number : 8400004

Recruiting

Gainesville, Florida, United States, 32607

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

Recruiting

St. Petersburg, Florida, United States, 33711

East Florida Eye Institute- Site Number : 8400038

Recruiting

Stuart, Florida, United States, 34994

Southeast Retina Center- Site Number : 8400044

Recruiting

Augusta, Georgia, United States, 30909

University Retina - Lemont- Site Number : 8400005

Recruiting

Lemont, Illinois, United States, 60439

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

Recruiting

Chevy Chase, Maryland, United States, 20815

Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003

Recruiting

Hagerstown, Maryland, United States, 21740

Retina Specialist- Site Number : 8400055

Recruiting

Towson, Maryland, United States, 21204

Sierra Eye Associates- Site Number : 8400021

Recruiting

Reno, Nevada, United States, 89502

North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400059

Recruiting

Wake Forest, North Carolina, United States, 27587-3803

Oregon Retina- Site Number : 8400017

Recruiting

Eugene, Oregon, United States, 97401

Mid Atlantic Retina - Bethlehem- Site Number : 8400031

Recruiting

Bethlehem, Pennsylvania, United States, 18017-9412

Erie Retina Research- Site Number : 8400035

Recruiting

Erie, Pennsylvania, United States, 16505

Charleston Neuroscience Institute - Ladson- Site Number : 8400016

Recruiting

Ladson, South Carolina, United States, 29456

Charleston Neuroscience Institute - Ladson- Site Number : 8400046

Recruiting

Ladson, South Carolina, United States, 29456

Texas Retina Associates - Arlington- Site Number : 8400056

Recruiting

Arlington, Texas, United States, 76012

Retina Consultants of Austin- Site Number : 8400015

Recruiting

Austin, Texas, United States, 78705

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

Recruiting

Austin, Texas, United States, 78750

Retina Consultants of Texas - Bellaire- Site Number : 8400019

Recruiting

Bellaire, Texas, United States, 77401

Retina Foundation of the Southwest- Site Number : 8400001

Recruiting

Dallas, Texas, United States, 75231

Texas Retina Associates - Dallas- Site Number : 8400006

Recruiting

Dallas, Texas, United States, 75231

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

Recruiting

San Antonio, Texas, United States, 78240

Retina Center of Texas (RCT) - Southlake- Site Number : 8400048

Recruiting

Southlake, Texas, United States, 76092

More Information

Sponsor

Sanofi

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.