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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07007065 | Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) | PHASE3 | RECRUITING | 561 | — | — | Nov 5, 2025 | Mar 1, 2033 | May 27, 2026 | 128 | United States, Austria +15 |
To assess the injection burden and the necessity for supplemental anti-VEGF injections over the first year of the study period across the different treatment groups.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 | EXPERIMENTAL | Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 administered via subretinal delivery one time. |
| Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 | EXPERIMENTAL | Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 administered via subretinal delivery one time. |
| Ranibizumab Control Group | EXPERIMENTAL | Ranibizumab administered via intravitreal injection as needed PRN |
| Name | Type | Description |
|---|---|---|
| Surabgene Lomparvovec (ABBV-RGX-314) | DRUG | subretinal injection |
| Ranibizumab Control | DRUG | intravitreal injection |
Inclusion Criteria: * Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \[Week -6\]) in the study eye. * Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye --CNV lesion characteristics as asses...