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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04514653 | RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD) | PHASE2 | ACTIVE NOT_RECRUITING | 146 | — | — | Aug 25, 2020 | Feb 1, 2027 | Feb 27, 2026 | 18 | United States |
The scale used is the early treatment diabetic retinopathy study (ETDRS) letter score from 0-100 and higher score being better vision.
| Arm | Type | Description |
|---|---|---|
| Ranibizumab control | ACTIVE_COMPARATOR | Control treatment arm |
| ABBV-RGX-314 Treatment Arm (Dose 1) | EXPERIMENTAL | ABBV-RGX-314 Dose 1 |
| ABBV-RGX-314 Treatment Arm (Dose 2) | EXPERIMENTAL | ABBV-RGX-314 Dose 2 |
| ABBV-RGX-314 Treatment Arm (Dose 3) | EXPERIMENTAL | ABBV-RGX-314 Dose 3 |
| ABBV-RGX-314 Treatment Arm (Dose 3) and Local Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 3 and Local Steroid |
| ABBV-RGX-314 Treatment Arm (Dose 3) and Topical Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 3 and Topical Steroid |
| ABBV-RGX-314 Treatment Arm (Dose 4) and Topical Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 4 and Topical Steroid |
| Name | Type | Description |
|---|---|---|
| Ranibizumab | BIOLOGICAL | Ranibizumab (anti-VEGF agent) |
| 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) |
| ABBV-RGX-314 Dose 3 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 3) |
| Local Steroid | DRUG | Local steroid |
| Topical Steroid | DRUG | Topical steroid |
| ABBV-RGX-314 Dose 4 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 4) |
Inclusion Criteria: * Age \>/= 50 and \</= 89 * Diagnosis of CNV secondary to age-related macular degeneration in the study eye. * Participants must have demonstrated a meaningful response to anti-VEGF therapy. * Willing and able to provide written, signed informed consent for this study. Exclusio...