A Phase 1/2 interventional study of SAR446597 and Sham Comparator in Geographic Atrophy, sponsored by Sanofi. Recruiting at 35 sites in 3 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Sanofi · Phase 1/2, Interventional, and Treatment
Among 131 studies in Geographic Atrophy with a site in United States — 35 open to participants now, 46 under way, 5 of them phase 3. Geographic Atrophy · United States.
Among the 131 studies in Geographic Atrophy with a site in United States, this one is the 52nd largest by planned enrollment of the 107 interventional ones, is one of 20 that started in 2025, is one of 17 in phase 1/2, reaches primary completion later than 18 of the 45 other live ones, and was the 119th registered.
188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.
This study's planned enrollment of 104 is above the median of 70 across 141 interventional studies indexed under Geographic Atrophy.
Browse Geographic Atrophy studies →35 of the 131 studies in Geographic Atrophy with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 40 Geographic Atrophy studies recruiting now, 31 (78%) set no upper age limit and 0 (0%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →131 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 20 started in 2025.
Median enrollment 98 across the 107 interventional studies, 138 across the 24 observational. Of the 78 that completed or were terminated, 40 (51%) have results posted.
109 of 131 have an industry lead sponsor. The 10 most frequent:
Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Sanofi has 1 study filed under Geographic Atrophy — fewer than ten, so there is no comparison to draw.
12 of the studies in Geographic Atrophy with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05949593Phase 3Belite Bio, IncPhase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy | 2027-06-30 |
| NCT06510816Phase 3Annexon, Inc.A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) | 2027-07-31 |
| NCT06769048Boehringer IngelheimA Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy | 2026-12-22 |
| NCT07747662University of Wisconsin, MadisonAdaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study | 2027-02 |
| NCT07144137Complement TherapeuticsA Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA) | 2027-03-31 |
Among the 131 studies in Geographic Atrophy with a site in United States, from their registry updates:
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Oct 2025 (actual). Primary completion is estimated for Oct 2027, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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