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

Study on Eye Injection for Vision Loss in Older Adults

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

This study investigates the safety and effectiveness of a one-time intravitreal injection for treating Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). Geographic Atrophy is a condition where parts of the retina waste away, leading to vision loss. The purpose of this study is to evaluate how well the investigational treatment works and how safe it is for participants with this condition.

Participants will receive either a one-time injection of the investigational medication or a sham treatment. The study will monitor participants for any changes in their vision and overall eye health. The study includes two parts: Part I focuses on dose escalation, while Part II involves dose expansion.

  • Who can participate: Participants must be 60 years or older with Geographic Atrophy due to Age-related Macular Degeneration. The study eye must meet specific visual acuity and lesion size requirements. People with other eye diseases, recent eye treatments, or significant uncontrolled illnesses cannot join.
  • Study details: Participants will receive a one-time injection into the eye. They will be monitored for changes in vision and eye health. A sham treatment, which looks like the investigational injection but contains no medicine, may be used for comparison.
  • Study timelines: The study will last approximately 2 years with an additional 3-year follow-up phase.
Updated on 17 Oct 2025. Study ID: NCT07215234

Find a study site near you

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
United States Only: Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language