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NCT07215234 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Geographic Atrophy, sponsored by Sanofi.

Recruiting
Registry status
Phase 1
Development phase
104
Enrollment target
13
Study locations

NCT07215234: Recruiting Phase 1 study of Geographic Atrophy, sponsored by Sanofi.

NCT07215234 is a Phase 1 study of Geographic Atrophy that is actively recruiting participants, run by Sanofi. The registered enrollment target is 104 participants, below the 218-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (52% lower). The trial reports 13 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07215234, a Phase 1 study of Geographic Atrophy, is actively recruiting participants, sponsored by Sanofi.

RECRUITING
Registry status
Phase 1
Development phase
104 participants
Enrollment target
13
Study locations

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

Geographic Atrophy

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
Sanofi

713 total trials

What NCT07215234 shows while recruiting

NCT07215234 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 218-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (52% lower).

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.

NCT07215234 lists 13 locations in 7 states (Texas, Arizona, Florida).

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.

What interventions are being tested in trial NCT07215234?

The interventions under investigation include: SAR446597 (DRUG), Sham Comparator (DRUG).

Who is sponsoring clinical trial NCT07215234?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Geographic Atrophy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07215234's enrollment target sits among peer trials

104 15th of 27 higher than 13 of 27 other Geographic Atrophy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Geographic Atrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07215234

Source: ClinicalTrials.gov NCT07215234, the US trial registry maintained by the National Library of Medicine. NCT07215234 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.