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RECRUITING Phase 1

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

NCT07215234 · View on ClinicalTrials.gov ↗

Study 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).

Conditions Studied

Interventions

  • DRUG SAR446597
  • DRUG Sham Comparator

Study Locations (13)

Texas

  • Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007 — Austin
  • Retina Foundation of the Southwest- Site Number : 8400001 — Dallas
  • Texas Retina Associates - Dallas- Site Number : 8400006 — Dallas
  • Retinal Consultants of Texas - San Antonio- Site Number : 8400012 — San Antonio

Arizona

  • Associated Retina Consultants - Peoria- Site Number : 8400011 — Peoria
  • Retina Macula Institute of Arizona- Site Number : 8400028 — Scottsdale

Florida

  • Vitreo Retinal Associates - Gainesville- Site Number : 8400004 — Gainesville
  • Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002 — St. Petersburg

Maryland

  • The Retina Group of Washington - Chevy Chase- Site Number : 8400009 — Chevy Chase
  • Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 — Hagerstown

Illinois

  • University Retina - Lemont- Site Number : 8400005 — Lemont

Oregon

  • Oregon Retina- Site Number : 8400017 — Eugene

Pennsylvania

  • Mid Atlantic Retina- Site Number : 8400031 — Bethlehem

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2025-10-09
Est. Completion 2032-07-22
Phase Phase 1

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07215234

The ClinicalTrials.gov registry entry for NCT07215234 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Geographic Atrophy appearing as the primary indexed condition, and to 2 interventions — of which SAR446597 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07215234 reports 13 study locations spanning 7 distinct geographic areas — top geographies include Texas, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07215234 about?

NCT07215234 is a clinical study titled "A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration". 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 ye...

What is the current status of trial NCT07215234?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2025-10-09. Estimated completion is 2032-07-22.

What conditions does trial NCT07215234 study?

This clinical trial studies the following conditions: Geographic Atrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07215234?

The interventions under investigation include: SAR446597 (DRUG), Sham Comparator (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07215234?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07215234 being conducted?

This trial has 13 study locations across Arizona, Florida, Illinois, Maryland, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial