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

Study acronym: DME
StatusRecruiting
PhasePhase 1
SponsorOcugen
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Enrollment target: 30 to 24v7 Show 5 more changesShow less
    • Eligibility criteria shortened, about 60 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Primary endpoints revised (3)
    • Study description shortened, about 74 words
    • Study arms: 5 to 4
  3. Primary completion date: Sep 30, 2025 to Jul 31, 2026v6 Show 8 more changesShow less
    • Enrollment target: 28 to 30
    • Study completion date: Oct 31, 2025 to Jul 31, 2026
    • Interventions: OCU200 High Dose (Drug), OCU200 Low Dose (Drug), OCU200 Medium Dose (Drug) to OCU200 (Drug)
    • Eligibility criteria expanded, about 117 words
    • Secondary endpoints: 10 to 6
    • Study description expanded, about 37 words
    • Site contacts updated at 1 of 5 sites
    • Study arms: 4 to 5
  4. Site contacts updated at 1 of 5 sitesv5
  5. Site contacts updated at 1 of 5 sitesv4
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  1. Site details revised at 2 of 5 sites
    • Eligibility criteria expanded, about 4 words
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary completion date: Sep 2023 to Sep 30, 2025
    • Start date changed from estimate of Apr 2023 to Jan 13, 2024
    • Study sites: 0 to 5
    • Study completion date: Sep 2023 to Oct 31, 2025
    • Eligibility criteria shortened, about 148 words
    • Study description shortened, about 359 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ocugen
6 trials monitored
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A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
Trial Details
NCT Number NCT05802329
Lead Sponsor Ocugen
Conditions
(from sponsor)		 Center Involved Diabetic Macular Edema, Diabetic Macular Edema
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov