Actively Recruiting
Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
Led by Ocugen · Updated on 2025-12-03
24
Participants Needed
5
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
CONDITIONS
Official Title
Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Decreased visual acuity primarily due to diabetic macular edema
- Central-involved diabetic macular edema with specific central retinal subfield thickness values measured by SD-OCT
- Best corrected visual acuity between 24 and 78 letters on ETDRS chart
- Clear enough ocular media and ability to cooperate for good quality retinal imaging
- No prior anti-VEGF injection or at least 2 consecutive anti-VEGF injections with incomplete resolution of retinal thickness within 1 year
- Last anti-VEGF injection at least six weeks (45 days) before study treatment in the study eye
You will not qualify if you...
- Any condition preventing clear view of retina (e.g., significant cataract, vitreous hemorrhage)
- Uncontrolled hypertension
- Uncontrolled glaucoma
- Other eye diseases in the study eye aside from center-involved diabetic macular edema
- Intravitreal or periocular steroid treatment within 3 months before screening
- Any eye surgery within 3 months before screening in the study eye
- Poorly controlled diabetes (HbA1c ≥ 10%)
- History of retinal detachment or other retinal vascular disease in the study eye
- Focal or pan-retinal laser treatment within 3 months before screening in the study eye
- Presence of inherited retinal disease or history of proliferative diabetic retinopathy
- History of kidney disease including stage 3b or worse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Advanced Research LLC
Deerfield Beach, Florida, United States, 33064
Actively Recruiting
2
Erie Retina Research, LLC
Erie, Pennsylvania, United States, 16507
Actively Recruiting
3
Retina Consultants of Texas Research Centers
Bellaire, Texas, United States, 77401
Actively Recruiting
4
Retina Consultants of America
Southlake, Texas, United States, 76092
Actively Recruiting
5
Gundersen Health System
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
Research Team
R
Roshan A George, MD, MPH
CONTACT
O
Oscar Cuzzani, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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