Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
Part of paid clinical trials in Deerfield Beach, Florida.
- Sponsor
- Ocugen
- Study ID
- NCT05802329
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Center Involved Diabetic Macular Edema
- Diabetic Macular Edema
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- OCU200 — DRUGIntravitreal Injection
Study Details
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
Key Dates
- Start date
- Jan 13, 2024
- Status verified
- Nov 2025
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 13+3 participants will receive intravitreal injection of OCU200 (0.5 mg/mL concentration).
- Experimental: Cohort 23+3 participants will receive intravitreal injection of OCU200 (1 mg/ML concentration).
- Experimental: Cohort 33+3 participants will receive intravitreal injection of OCU200 (2 mg/mL concentration).
- Experimental: Cohort 43+3 participants will receive intravitreal injection of OCU200 (5 mg/mL concentration).
Primary Outcome Measure
Study Drug-related adverse events (SDAE) [ Time Frame: 24 weeks ]
Central Contacts
- Roshan A George, MD, MPH845-664-1505
- Oscar Cuzzani, MD, PhD
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Advanced Research LLC | Deerfield Beach | Florida | 33064 | Samarth Shah, MD, Ph.D Shailesh Gupta, MD (PRINCIPAL_INVESTIGATOR) |
| Erie Retina Research, LLC | Erie | Pennsylvania | 16507 | David Almeida, MD, MDA, PhD (PRINCIPAL_INVESTIGATOR) |
| Retina Consultants of Texas Research Centers | Bellaire | Texas | 77401 | Charles Wykoff, MD (PRINCIPAL_INVESTIGATOR) |
| Retina Consultants of America | Southlake | Texas | 76092 | Emily Gonzales R.Gary Lane, MD (PRINCIPAL_INVESTIGATOR) |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | Chase Penzkover Syed M Shah, MD (PRINCIPAL_INVESTIGATOR) |
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