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

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, asassessed with spectral-domain optical coherence tomography (SD-OCT) of:

4. ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on HeidelbergSpectralis

5. ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus

6. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart

7. Sufficient ocular media clarity, pupillary dilation and participant cooperation topermit acquisition of good quality retinal imaging

8. No history of prior anti-VEGF injection or history of at least 2 consecutiveintravitreal anti-VEGF injection (less than 7 weeks apart) with incompleteresolution 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 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 screeningvisit

6. Any ocular surgery within 3 months prior to the screening visit in the study eye

7. Uncontrolled/poorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%)

8. History of retinal detachment in the study eye or other retinal vascular disease inthe study eye

9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months priorto the screening visit

10. Presence of any inherited retinal disease or history of proliferative diabeticretinopathy

11. History of Renal disease including stage 3b or worse