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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07441642 | A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration | PHASE2 | RECRUITING | 272 | — | — | Mar 9, 2026 | Aug 22, 2029 | Jun 8, 2026 | 28 | United States, Australia +10 |
To evaluate the dose response relationship of FWY003 on GA lesion area in participants with GA secondary to age-related macular degeneration (AMD).
| Arm | Type | Description |
|---|---|---|
| FWY003 dose level 1 | EXPERIMENTAL | Participants will receive FWY003 dose level 1 |
| FWY003 dose level 2 | EXPERIMENTAL | Participants will receive FWY003 dose level 2 |
| FWY003 dose level 3 | EXPERIMENTAL | Participants will receive FWY003 dose level 3 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo |
| Name | Type | Description |
|---|---|---|
| FWY003 | DRUG | FWY003 arm participants will receive a specific dose of FWY003 |
| Placebo | DRUG | Placebo arm participants will receive placebo |
Inclusion Criteria: Male or female participants ≥ 50 years of age. * A diagnosis of GA secondary to AMD in at least one eye (study eye). If both eyes qualify, then the eye with the better BCVA would be assigned as study eye. 1. Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), ...