NCT05802329

Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)

A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Ocugen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema

Detailed description

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.

Conditions

• Center Involved Diabetic Macular Edema
• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	OCU200	Intravitreal Injection

Timeline

• Start date: 2024-01-13
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2023-04-06
• Last updated: 2025-12-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study