A Phase 1 interventional study of OCU200 in Center Involved Diabetic Macular Edema and Diabetic Macular Edema, sponsored by Ocugen. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Ocugen · Phase 1, Interventional, and Treatment
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
This is a multicenter, open-label, dose ranging study with 4 cohorts in the dose-escalation portion of the study. An accelerated 3+3 design with parallel and sequential dosing will be used.
Under the escalation design, 12 subjects will be enrolled if there are no DLTs and up to 24 subjects under the condition that exactly 1 of the 3 subjects of every cohort if determined to have a DLT.
Each subject will receive a total of 2 intravitreal injections of OCU200 6 weeks apart.
The DSMB will review the sentinel subject 1 week safety data post dosing in every cohort of all 3 subjects.
Cohort 1: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 2: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 3: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 4: 3+3 participants will receive intravitreal injection of OCU200.
Ocugen is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:
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:
3+3 participants will receive intravitreal injection of OCU200 (0.5 mg/mL concentration).
Drug: OCU200
3+3 participants will receive intravitreal injection of OCU200 (1 mg/ML concentration).
Drug: OCU200
3+3 participants will receive intravitreal injection of OCU200 (2 mg/mL concentration).
Drug: OCU200
3+3 participants will receive intravitreal injection of OCU200 (5 mg/mL concentration).
Drug: OCU200
Intravitreal Injection
Study Drug-related adverse events (SDAE)
Counts, frequencies and percentages of SDAEs.
Time frame: 24 weeks
Treatment-emergent adverse events (TEAEs)
Counts, frequencies and percentages TEAEs.
Time frame: 24 weeks
Serious adverse events (SAEs)
Counts, frequencies and percentages of SAEs.
Time frame: 24 weeks
Best-corrected visual acuity (BCVA)
Measured as the ETDRS letter score on the EVA tester or E-ETDRS charts.
Time frame: 24 Weeks (Changes from baseline)
Intraocular pressure (IOP)
IOP measurement by applanation or rebound tonometry.
Time frame: 24 weeks(Changes from baseline)
Color fundus photography
Color fundus photographs will be taken to evaluate retinal anatomy and grade diabetic retinopathy severity scale (DRSS).
Time frame: 24 Weeks(Changes from baseline)
Spectral Domain Optical Coherence Tomography (SD-OCT)
SD-OCT will be utilized to assess retinal thickness. OCT images and scans will be transmitted to a central reading center for independent analysis.
Time frame: 24 Weeks(Changes from baseline)
Spectral Domain Optical Coherence Tomography Angiography (SD-OCTA)
SD-OCTA will be utilized to assess retinal vasculature and images will be transmitted to a central reader for independent analysis.
Time frame: 24 weeks (Changes from baseline)
Wide-field Fluorescein Angiography (wf-FA)
wf-FA will be conducted at screening and EOS visits to assess central and peripheral vasculature.
Time frame: 24 weeks (Changes from baseline)
Improvement of diabetic retinopathy severity scale (DRSS)
Proportion of participants with ≥ 2-step improvement of diabetic retinopathy severity scale (DRSS)
Time frame: 24 weeks
Change from baseline in BCVA letters.
Dose response as assessed by mean change from baseline in BCVA letters and mean number of injections by study visit
Time frame: 24 weeks
Reduction of CST
The proportion of participants having a ≥ 10% reduction of CST at Week 13 and Week 19
Time frame: 24 Weeks
Plan to share: No
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