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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04857996 | Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD) | PHASE2 | COMPLETED | 65 | — | — | Jun 25, 2021 | Apr 6, 2023 | May 16, 2024 | 22 | United States, Canada |
The systemic safety and tolerability is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs) by System organ class Preferred Term.
Ocular Safety is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs). Ocular TEAEs consisted of progression of disease or were related to the IVT injection component of the UBX1325 drug administration process
| Arm | Type | Description |
|---|---|---|
| UBX1325 | EXPERIMENTAL | - |
| Sham Control | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| UBX1325 | DRUG | Patients will be administered a single 50 μL UBX1325 IVT injection |
| Sham | OTHER | Sham procedure |
Inclusion Criteria: * Patients aged ≥ 18 years. * Diabetic retinopathy patients (nonproliferative (NPDR) and proliferative (PDR)) with DME (ETDRS-DRSS Score at 65C \[or DR severity level of 8\]or less severe as determined by a Central Reading Center), who had at least 2 anti-VEGF intravitreal (IVT)...
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|---|---|---|---|---|
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