Tests SAR446597 injection for geographic atrophy from age-related macular degeneration

Trial details

Who runs it

Sanofi

Trial code

NCT07215234

Record updated

20 October 2026

Original description

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).Read full original descriptionShow less

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

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).

Inclusion: 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: Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye; 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 active ocular infection in the study eye in 6 months prior to screening; Previous gene therapy in either eye; GA in the study eye caused by a disease different than AMD; 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; History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye; Presence of active ocular or periocular infections; History of uveitis or scleritis 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; Active uncontrolled glaucoma in the study eye.

ClinicalTrials.gov NCT07215234