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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05802329 | Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME) | PHASE1 | RECRUITING | 24 | — | — | Jan 13, 2024 | Jul 31, 2026 | Dec 3, 2025 | 5 | United States |
Counts, frequencies and percentages of SDAEs.
Counts, frequencies and percentages TEAEs.
Counts, frequencies and percentages of SAEs.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 3+3 participants will receive intravitreal injection of OCU200 (0.5 mg/mL concentration). |
| Cohort 2 | EXPERIMENTAL | 3+3 participants will receive intravitreal injection of OCU200 (1 mg/ML concentration). |
| Cohort 3 | EXPERIMENTAL | 3+3 participants will receive intravitreal injection of OCU200 (2 mg/mL concentration). |
| Cohort 4 | EXPERIMENTAL | 3+3 participants will receive intravitreal injection of OCU200 (5 mg/mL concentration). |
| Name | Type | Description |
|---|---|---|
| OCU200 | DRUG | Intravitreal Injection |
Inclusion Criteria: 1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus 2. Decreased visual acuity attributable primarily to DME 3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of: 1. ≥ 320 but ≤...