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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03585556 | AAVCAGsCD59 for the Treatment of Wet AMD | PHASE1 | COMPLETED | 25 | — | — | Sep 13, 2018 | Jan 18, 2022 | Mar 30, 2025 | 2 | United States |
Measure the number of intravitreal anti VEGF injections from Month 1 through Month 12 following an intravitreal injection of AAVCAGsCD59 at Day 7
| Arm | Type | Description |
|---|---|---|
| AAVCAGsCD59 Treated Arm | EXPERIMENTAL | An anti-VEGF injection will be given at Day 0 followed by an intravitreal injection of AAVCAGsCD59 at Day 7. All eyes will then be treated with intravitreal anti-VEGF monthly as needed based on disease activity. |
| Name | Type | Description |
|---|---|---|
| Intravitreal anti-VEGF | DRUG | Intravitreal injection of anti-VEGF at Day 0 then monthly as needed |
| Intravitreal AAVCAGsCD59 | BIOLOGICAL | An intravitreal injection of AAVCAGsCD59 will occur at Day 7 once |
| Oral prednisolone | DRUG | A 7 day tapering dose of oral prednisone will be taken at Day 30 by all patients |
Inclusion Criteria: 1. Men or women 50 years of age or older. 2. Treatment naive Wet AMD with no evidence of subretinal fibrosis under the fovea. 3. Presence of intraretinal and/or subretinal fluid on OCT. 4. Best corrected visual acuity (BCVA) Snellen equivalent 20/25 to 20/400 in the study eye us...