NCT07215234 A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
| NCT ID | NCT07215234 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sanofi |
| Condition | Geographic Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-10-09 |
| Primary Completion | 2027-10-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 104 participants in total. It began in 2025-10-09 with a primary completion date of 2027-10-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Trial Transparency email recommended (Toll free for US & Canada)
✉ contact-us@sanofi.com📞 800-633-1610
Frequently Asked Questions
Who can join the NCT07215234 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Geographic Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07215234 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07215234 currently recruiting?
Yes, NCT07215234 is actively recruiting participants. Contact the research team at contact-us@sanofi.com for enrollment information.
Where is the NCT07215234 trial being conducted?
This trial is being conducted at Peoria, United States, Scottsdale, United States, Gainesville, United States, St. Petersburg, United States and 11 additional locations.
Who is sponsoring the NCT07215234 clinical trial?
NCT07215234 is sponsored by Sanofi. The trial plans to enroll 104 participants.