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

Prior treatment

• Concurrent disease in the study eye, other than central-involved DME
• Intravitreal or periocular steroid treatment within 3 months prior to the screening visit
• Any ocular surgery within 3 months prior to the screening visit in the study eye
• Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit

Other illness

• Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)
• Uncontrolled hypertension
• History of retinal detachment in the study eye or other retinal vascular disease in the study eye
• Presence of any inherited retinal disease or history of proliferative diabetic retinopathy
• History of Renal disease including stage 3b or worse

Lab values

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

Other

• Uncontrolled glaucoma

• Diagnosis of Type 1 or Type 2 Diabetes Mellitus
• Decreased visual acuity attributable primarily to DME
• Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:
  • ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis
  • ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus
• BCVA ≤ 78 and ≥ 24 letters on ETDRS chart
• Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging
• 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.