Tests OCU200 for swelling in the center of the retina caused by diabetes
Tests OCU200, a new drug, in adults with diabetic macular edema.
Plain-language title generated from the registry record
Registry title: Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
Key facts
- Where
- Bellaire, Deerfield Beach, Erie, La Crosse, and Southlake, United StatesSee the 5 sites
- Phase
- Phase 1
Where in United States
- Retina Consultants of Texas Research CentersBellaire, United StatesTaking people
- Advanced Research LLCDeerfield Beach, United StatesTaking people
- Erie Retina Research LLCErie, United StatesTaking people
- Gundersen Health SystemLa Crosse, United StatesTaking people
- Retina Consultants of AmericaSouthlake, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ocugen
- Trial code
- NCT05802329
- Record updated
- 31 July 2026
- Original description
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edemaRead full original descriptionShow less
A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
Inclusion: 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: 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; 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; Uncontrolled/poorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%); Uncontrolled glaucoma.