Assessing OCU200 for Diabetic Macular Edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study evaluates the safety and efficacy of OCU200 in patients with center-involved diabetic macular edema (DME). It is a multicenter, open-label trial that employs a dose-escalation design with three cohorts receiving varying doses of OCU200, and an additional cohort receiving OCU200 in combination with Lucentis. The study aims to enroll up to 28 participants, with a focus on monitoring safety data through a Data Safety Monitoring Board (DSMB). Participants will receive intravitreal injections of OCU200 at low, medium, or high doses based on their cohort assignment.

Why it matters

Who can join: the full rules

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

   1. ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis
   2. ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus
4. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart
5. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging
6. 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:

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 screening visit
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 in the study eye
9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit
10. Presence of any inherited retinal disease or history of proliferative diabetic retinopathy
11. History of Renal disease including stage 3b or worse

Where it's running

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

Study contacts

• Study coordinator: Roshan A George, MD, MPH
• Email: roshan.george@ocugen.com
• Phone: 845-664-1505

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.