A Phase 1/2 interventional study of SAR446597 and Sham Comparator in Geographic Atrophy, sponsored by Sanofi. Recruiting at 32 sites in 3 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Sanofi · Phase 1/2, Interventional, and Treatment
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).
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.
Drug: SAR446597
Participants will receive SAR at a dose specified for each arm.
Drug: SAR446597
Participants will receive SAR at a dose specified for each arm.
Drug: SAR446597
Participants will receive Sham at a dose specified for each arm.
Drug: Sham Comparator
Intravitreal injection
Sham injection
Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs)
Time frame: Day 1 to Week 104
Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs)
Time frame: Day 1 to Week 104
Change in square root-transformed (mm) and untransformed area (mm2) of GA
Time frame: Baseline, Week 52, Week 104
Change in best-corrected visual acuity (BCVA) from baseline to Week 52 and Week 104 following SAR446597 administration measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Time frame: Baseline, Week 52, Week 104
Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye
Time frame: Baseline, Week 52, Week 104
Incidence and severity of ocular and non-ocular TEAEs and TESAEs including clinically significant changes in safety parameters
Time frame: Week 260 or End of Study
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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