A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Investigational Intravitreal Injection for Geographic Atrophy in Age-related Macular Degeneration

Recruiting
60 years or above
All
Phase 1/2
104 participants needed
3 Locations

Study Overview

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Geographic Atrophy
  • Age: 60 years or above
  • Gender: All

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.

This study investigates Geographic Atrophy secondary to Age-related Macular Degeneration. Participants will receive a one-time intravitreal injection of an investigational medication to evaluate its effects.

The study focuses on evaluating the safety and efficacy of the investigational medication for treating Geographic Atrophy associated with Age-related Macular Degeneration.

  • Who can participate: Participants must be 60 years or older with a diagnosis of Geographic Atrophy secondary to Age-related Macular Degeneration. Key eligibility includes specific visual acuity and lesion size criteria.
  • Study details: Participants will receive a one-time injection of the investigational medication or a sham. The study will assess the effects on eye health and vision.
  • Study timelines: The study will last 2 years for the core phase, followed by a 3-year extended follow-up phase.
Updated on 20 Apr 2026. Study ID: NCT07215234

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