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OCU200

Phase 1

Center Involved Diabetic Macular Edema | Small molecule | Ophthalmology |Ocugen, Inc.|Last Updated: Dec 3, 2025

Success Probability
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Market & Valuation
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical trial landscape

OCU200 · 1 trial · 2 indications

Phase 1 1
NCT05802329Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)Center Involved Diabetic Macular Edema
RECRUITING24 Analytics
PHASE1RECRUITING
Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
Center Involved Diabetic Macular Edema
NCT0580232924
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Study Endpoints
Primary Endpoints
Study Drug-related adverse events (SDAE)
24 weeks

Counts, frequencies and percentages of SDAEs.

Treatment-emergent adverse events (TEAEs)
24 weeks

Counts, frequencies and percentages TEAEs.

Serious adverse events (SAEs)
24 weeks

Counts, frequencies and percentages of SAEs.

Secondary Endpoints
Best-corrected visual acuity (BCVA)
24 Weeks (Changes from baseline)
Intraocular pressure (IOP)
24 weeks(Changes from baseline)
Color fundus photography
24 Weeks(Changes from baseline)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL3+3 participants will receive intravitreal injection of OCU200 (0.5 mg/mL concentration).
Cohort 2EXPERIMENTAL3+3 participants will receive intravitreal injection of OCU200 (1 mg/ML concentration).
Cohort 3EXPERIMENTAL3+3 participants will receive intravitreal injection of OCU200 (2 mg/mL concentration).
Cohort 4EXPERIMENTAL3+3 participants will receive intravitreal injection of OCU200 (5 mg/mL concentration).
Interventions
NameTypeDescription
OCU200DRUGIntravitreal Injection
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites5

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 ≤...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05802329primaryCompletionDate: changed
LOWMay 24, 2026NCT05802329studyFirstPostDate: changed