Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07215234 | A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration | PHASE1 | RECRUITING | 104 | — | — | Oct 9, 2025 | Jul 22, 2032 | Apr 21, 2026 | 17 | United States, Australia |
| Arm | Type | Description |
|---|---|---|
| Part I - SAR446597 open-label (OL) | EXPERIMENTAL | Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants. |
| Part II - SAR446597 Dose A | EXPERIMENTAL | Participants will receive SAR at a dose specified for each arm. |
| Part II - SAR446597 Dose B | EXPERIMENTAL | Participants will receive SAR at a dose specified for each arm. |
| Part II - Sham control | SHAM_COMPARATOR | Participants will receive Sham at a dose specified for each arm. |
| Name | Type | Description |
|---|---|---|
| SAR446597 | DRUG | Intravitreal injection |
| Sham Comparator | DRUG | Sham injection |
Inclusion Criteria: * 60 years old or above * Participants with diagnosis of GA secondary to age-related macular degeneration (AMD) * Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal o...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | — | Pegcetacoplan |