Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)

Eligibility 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 if male or ≥ 305 µm if female on Heidelberg Spectralis
• 2. ≥ 305 if male or ≥ 290 if female on Zeiss Cirrus
• 3. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart
• 4. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging
• 5. No history of prior anti-VEGF injection for treatment of DME or history of at least 2 consecutive anti-VEGF intravitreal injection
• 1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)
• 2. Uncontrolled hypertension
• 3. Uncontrolled glaucoma
• 4. Concurrent disease in the study eye, other than central-involved DME
• 5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit
• 6. Any ocular surgery within 3 months prior to the screening visit in the study eye
• 7. Uncontrolled/poorly controlled diabetes
• 8. History of retinal detachment in the study eye or other retinal vascular disease in the study eye
• 9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit
• 10. Presence of any inherited retinal disease or proliferative diabetic retinopathy