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

Recruiting now · Phase 1

Conditions studied: Center Involved Diabetic Macular Edema, Diabetic Macular Edema

In brief

A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema

Key facts

Study ID

NCT05802329

Run by

Ocugen

People needed

24

Starts

2024-01-13

Expected to finish

2026-07-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)
• Uncontrolled hypertension
• Uncontrolled glaucoma
• 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
• Uncontrolled/poorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%)
• History of retinal detachment in the study eye or other retinal vascular disease in the study eye
• Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit
• Presence of any inherited retinal disease or history of proliferative diabetic retinopathy
• History of Renal disease including stage 3b or worse

Where it is running

• Advanced Research LLC — Deerfield Beach, Florida, United States (enrolling)
• Erie Retina Research, LLC — Erie, Pennsylvania, United States (enrolling)
• Retina Consultants of Texas Research Centers — Bellaire, Texas, United States (enrolling)
• Retina Consultants of America — Southlake, Texas, United States (enrolling)
• Gundersen Health System — La Crosse, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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