NCT05802329 · Ocugen
Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
(DME)
What this study is about
A Phase 1 study to assess the safety and effectiveness of OCU200 for center-involved diabetic macular edema
View original scientific description
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Deerfield Beach, Florida
- Erie, Pennsylvania
- Bellaire, Texas
- Southlake, Texas
- La Crosse, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 3, 2025 · Source of record for eligibility and locations