Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-RGX-314 Dose 1 · 2 trials · 8 indications
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
To evaluate the effect of ABBV-RGX-314 on DR by the ETDRS DRSS at Week 48.
To evaluate the effect of ABBV-RGX-314 on BCVA at Week 54.
| 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 |
| Part 1: Observation Control Arm | NO_INTERVENTION | Observation Control |
| Part 1: ABBV-RGX-314 Treatment Arm (Dose 1) | EXPERIMENTAL | ABBV-RGX-314 Dose 1 |
| Part 1: ABBV-RGX-314 Treatment Arm (Dose 2) | EXPERIMENTAL | ABBV-RGX-314 Dose 2 |
| Part 1: ABBV-RGX-314 Treatment Arm (Dose 3) and Topical Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 3 and Topical Steroid |
| Part 2: ABBV-RGX-314 Treatment Arm (Dose 4) and Topical Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 4 and Topical Steroid |
| Part 2: Aflibercept Control | ACTIVE_COMPARATOR | Control treatment arm |
| 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 |
| ABBV-RGX-314 Dose 3 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 3) |
| Topical Steroid | DRUG | Topical Steroid |
| ABBV-RGX-314 Dose 4 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 4) |
| Aflibercept | BIOLOGICAL | Aflibercept |
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...