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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07482176 | Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS) | PHASE3 | RECRUITING | 284 | — | — | Mar 16, 2026 | Oct 20, 2031 | May 20, 2026 | 46 | United States |
| NCT06856577 | Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration | PHASE3 | ACTIVE NOT_RECRUITING | 311 | — | — | Feb 28, 2025 | Nov 23, 2030 | May 22, 2026 | 75 | United States |
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
| Arm | Type | Description |
|---|---|---|
| Ixo-vec | EXPERIMENTAL | Participants will receive 3 monthly loading doses of aflibercept 2 mg IVT, a single IVT injection of Ixo-vec 6 x 10\^10 vg/eye at Week 1, and sham injections every 8 weeks. |
| Aflibercept | ACTIVE_COMPARATOR | Participants will receive 3 monthly loading doses of aflibercept 2 mg IVT, a sham injection at Week 1, and aflibercept 2 mg IVT every 8 weeks. |
| Name | Type | Description |
|---|---|---|
| Ixo-vec | GENETIC | Ixo-vec will be administered intravitreally. |
| Aflibercept | DRUG | Aflibercept will be administered intravitreally. |
Inclusion Criteria: 1. Able and willing to provide informed consent (or have a legally authorized representative who is able and willing to provide informed consent) prior to any study assessments and procedures and comply with the study requirements and visits. 2. Male or female with a diagnosis o...