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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03066258 | Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial | PHASE1 | COMPLETED | 42 | — | — | Mar 29, 2017 | Jun 17, 2021 | May 16, 2023 | 8 | United States |
Participants with ocular and non-ocular AEs and SAEs through 26 weeks (24 weeks following RGX-314 administration)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 3E9 GC (genome copies)/eye of RGX-314 (E means the exponential constant) |
| Cohort 2 | EXPERIMENTAL | 1E10 GC/eye of RGX-314 |
| Cohort 3 | EXPERIMENTAL | 6E10 GC/eye of RGX-314 |
| Cohort 4 | EXPERIMENTAL | 1.6E11 GC/eye of RGX-314 |
| Cohort 5 | EXPERIMENTAL | 2.5E11 GC/eye of RGX-314 |
| Name | Type | Description |
|---|---|---|
| RGX-314 | GENETIC | RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein |
Inclusion Criteria: 1. Patients ≥ 50 and ≤ 89 years with a diagnosis of subfoveal CNV (Choroidal neovascularization) secondary to AMD in the study eye receiving prior intravitreal anti-VEGF therapy. 2. BCVA (Best Corrected Visual Acuity) between ≤20/63 and ≥20/400 (≤63 and ≥19 Early Treatment Diabe...