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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05956626 | A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease | PHASE2 | ACTIVE NOT_RECRUITING | 51 | — | — | Aug 25, 2023 | Sep 28, 2026 | Apr 6, 2026 | 14 | United States |
Change in the area of atrophy will be evaluated from the baseline measurements, using FAF to assess the loss of retinal layers.
Safety will be determined by the number of ocular and non-ocular Study Drug-related adverse events (SDAE), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
| Arm | Type | Description |
|---|---|---|
| Phase 2/3 Randomized Treatment Arm | EXPERIMENTAL | Subjects will receive a single subretinal injection of 200uL OCU410ST in concentration of 1.5 x 10E11vg/mL |
| Phase 2/3 Randomized Control Arm | NO_INTERVENTION | Subjects will not receive any active study intervention |
| Name | Type | Description |
|---|---|---|
| OCU410ST | DRUG | Subretinal Administration of OCU410ST |
Phase 2/3 Inclusion Criteria (applicable for both adult and pediatric subjects): 1. Males or females aged ≥5 years at the time of consent. 2. Subjects who have confirmed clinical and CLIA certified or equivalent genetic diagnosis of Stargardt disease (including ABCA4 related retinopathies). 3. Adul...