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A Phase 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema

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Trial Profile

A Phase 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 22 Nov 2024

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At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Diabetic macular oedema
  • Focus Registrational; Therapeutic Use
  • Acronyms DIAMOND; DIAMOND 1
  • Sponsors Oculis Pharma
  • Most Recent Events

    • 21 Oct 2024 According to an Oculis Pharma media release, Substantial patient enrollment progress achieved since the end of Q2 2024 through early October, with ~70% of patients enrolled in this trial, company accelerates the patient enrollment and expansion of the DIAMOND program committees with globally renowned retina experts.
    • 15 Oct 2024 According to an Oculis Pharma media release, results with OCS-01 eye drops in DME from Stage 1 of the DIAMOND program (DIAMOND-1 and DIAMOND-2) at Week 12 and will present the design of Stage 2 to assess the efficacy and safety of OCS-01 eye drops for the treatment of DME at Week 52 will be presented at Eyecelerator 2024, ahead of the American Academy of Ophthalmology Annual Meeting.
    • 27 Aug 2024 According to an Oculis media release, patient enrollment through the end of June exceeded the Companys expectations and was at 35% and 23% for DIAMOND-1 and DIAMOND-2, respectively.

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