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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05275205 | Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION) | PHASE2 | COMPLETED | 51 | — | — | Mar 2, 2022 | Jul 25, 2023 | Aug 7, 2024 | 14 | United States |
Ocular and systemic safety and tolerability of a repeat IVT injection of UBX1325 compared to active-control (aflibercept) evaluated by treatment emergent adverse events (TEAEs) through Week 24
| Arm | Type | Description |
|---|---|---|
| UBX1325 | EXPERIMENTAL | - |
| Aflibercept (EYLEA ®) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| UBX1325 injection 50 μL | DRUG | Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28 |
| EYLEA® (aflibercept) Injection 2 mg (0.05mL) | DRUG | Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28. |
Inclusion Criteria: * Patients aged ≥50 years. * Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening and Day 1 * BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 ...