Ocugen
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
This is a multicenter, open-label, dose ranging study with 4 cohorts in the dose-escalation portion of the study. An accelerated 3+3 design with parallel and sequential dosing will be used. Under the escalation design, 12 subjects will be enrolled if there are no DLTs and up to 24 subjects under the condition that exactly 1 of the 3 subjects of every cohort if determined to have a DLT. Each subject will receive a total of 2 intravitreal injections of OCU200 6 weeks apart. The DSMB will review the sentinel subject 1 week safety data post dosing in every cohort of all 3 subjects. Cohort 1: 3…
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…
Intravitreal Injection
Arctuva estimate
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