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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05407636 | Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD | PHASE3 | RECRUITING | 714 | — | — | Jan 13, 2022 | Nov 1, 2027 | Apr 20, 2026 | 181 | United States, Canada +8 |
To evaluate the noninferiority of ABBV-RGX-314 relative to aflibercept in mean change from Baseline BCVA at Week 54
AEs and SAEs through Week 50
| 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 | Aflibercept administered via intravitreal injection approximately every 8 weeks |
| Name | Type | Description |
|---|---|---|
| ABBV-RGX-314 Dose 1 | GENETIC | AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1) |
| ABBV-RGX-314 Dose 2 | GENETIC | AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2) |
| Aflibercept (EYLEA®) | BIOLOGICAL | 2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections |
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 choroidal neovascularization (CNV) secondary to AMD in the study eye previously treated with anti-VEGF 4. Must be pseudophakic (at least 12 weeks postc...