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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04704921 | Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD | PHASE2 | ACTIVE NOT_RECRUITING | 671 | — | — | Dec 29, 2020 | Nov 1, 2027 | Apr 28, 2026 | 89 | United States |
BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
Incidence of ocular AEs and any SAEs
| Arm | Type | Description |
|---|---|---|
| ABBV-RGX-314 Dose 1 | EXPERIMENTAL | ABBV-RGX-314 Dose 1 administered via subretinal delivery one time. |
| ABBV-RGX-314 Dose 2 | EXPERIMENTAL | ABBV-RGX-314 Dose 2 administered via subretinal delivery one time. |
| Control Arm | ACTIVE_COMPARATOR | Ranibizumab administered via intravitreal injection approximately every 28 days |
| Name | Type | Description |
|---|---|---|
| ABBV-RGX-314 | GENETIC | AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1) |
| Ranibizumab (LUCENTIS®) | BIOLOGICAL | 0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days |
Inclusion Criteria: 1. Age ≥ 50 years and ≤ 89 years 2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye 3. Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF 4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study e...