Tests SAR446597 injection for geographic atrophy from age-related macular degeneration
Tests a one-time eye injection of SAR446597 in people with geographic atrophy from macular degeneration.
Plain-language title generated from the registry record
Registry title: A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Key facts
- Where
- Adelaide, East Melbourne, and Sydney, AustraliaSee the 3 sites
- Phase
- Phase 1/2
Where in Australia
- AdelaideAdelaide, AustraliaTaking people
- East MelbourneEast Melbourne, AustraliaTaking people
- SydneySydney, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.