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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Associated Retina Consultants - Peoria- Site Number : 8400011
  Peoria, Arizona, United States Recruiting
• Retina Macula Institute of Arizona- Site Number : 8400028
  Scottsdale, Arizona, United States Recruiting
• Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400033
  Beverly Hills, California, United States Recruiting
• The Retina Partners- Site Number : 8400040
  Encino, California, United States Recruiting
• California Retina Consultants - Oxnard - North Ventura Road- Site Number : 8400014
  Oxnard, California, United States Recruiting
• Retinal Consultants - Sacramento - Parkcenter Drive- Site Number : 8400054
  Sacramento, California, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.