NCT05802329 Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
| NCT ID | NCT05802329 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ocugen |
| Condition | Center Involved Diabetic Macular Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-01-13 |
| Primary Completion | 2026-07-31 |
Trial Parameters
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Brief Summary
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
Eligibility Criteria
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 ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis 2. ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus 4. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart 5. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging 6. No history of prior anti-VEGF injection or history of at least 2 consecutive intravitreal anti-VEGF injection (less than 7 weeks apart) with incomplete resolution of CST within 1 year. Note: The last anti-VEGF injection must be administered at least six weeks (45 days) prior to the study treatment (Day 1) in the study eye. Exclusion Criteria: 1. Presence of any condition