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One-time intravitreal SAR446597 injection for geographic atrophy due to AMD

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

Phase1; Phase2 Interventional Sanofi · NCT07215234

This trial will try a single eye injection of SAR446597 to slow geographic atrophy in people 60 and older with AMD.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment104 (estimated)
Ages60 Years and up
SexAll
SponsorSanofi Industry-sponsored
Locations17 sites (Peoria, Arizona and 16 other locations)
Trial IDNCT07215234 on ClinicalTrials.gov

What this trial studies

This is a sequential Phase 1/2, two-part, multicenter trial testing the safety, tolerability, and potential efficacy of a one-time intravitreal injection of SAR446597 in participants with geographic atrophy secondary to age-related macular degeneration. Part I uses dose escalation to identify tolerable doses and Part II expands enrollment with a sham comparator to explore treatment effect. Each participant completes a core phase of about two years of follow-up and may enter a three-year extended follow-up phase. Key outcome measures include ocular safety events, changes in best-corrected visual acuity, and geographic atrophy lesion area on retinal imaging.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60 or older with geographic atrophy due to AMD in the study eye, meeting the trial’s visual acuity and lesion-size criteria and without prior anti-VEGF treatment or other ocular conditions that would interfere with outcomes.

Not a fit: Patients with GA from causes other than AMD, any evidence or history of neovascularization in the study eye, very advanced vision loss, or ocular/systemic issues expected to prevent vision improvement are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, a single injection could slow lesion growth and help preserve vision for people with GA from AMD.

How similar studies have performed: Other intravitreal complement-targeting therapies have shown some ability to slow GA progression in repeat-injection studies, but a one-time injection approach like SAR446597 is relatively novel and less well established.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Peoria, Arizona and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Geographic Atrophy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.