Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07215234 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 1/2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 31 to 32
  2. Trial sites expanded: 18 → 30 locations
  3. Study sites: 18 to 30
    • Eligibility criteria expanded, about 16 words
  4. Study sites: 17 to 18v10
  5. Trial sites expanded: 13 → 17 locationsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 12 to 13v8
  2. Study sites: 11 to 12
    • Eligibility criteria expanded, about 20 words
    v7
  3. Study sites: 8 to 11v6
  4. Study sites: 7 to 8v5
  5. Study sites: 5 to 7v4
  6. Study sites: 2 to 5v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Oct 15, 2025 to Oct 9, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
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).
Trial Details
NCT Number NCT07215234
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Geographic Atrophy
Related terms Geographic Atrophy
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov