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

Trial Profile

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

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 17 May 2024

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At a glance

  • Drugs OCU 200 (Primary)
  • Indications Diabetic macular oedema
  • Focus Adverse reactions
  • Sponsors Ocugen
  • Most Recent Events

    • 15 May 2024 According to a Ocugen media release, company continues to work with FDA to address comments to lift the clinical hold.
    • 05 May 2023 According to a Ocugen media release, In April, the IND was placed on clinical hold by the FDA prior to initiating the Phase 1 trial and the company plans to respond to the FDA promptly to get FDA clearance to initiate the Phase 1 trial.
    • 27 Feb 2023 According to an Ocugen media release, the company has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of OCU200 for the treatment of diabetic macular edema (DME).
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