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A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)

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A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2024

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At a glance

  • Drugs Tarcocimab tedromer (Primary) ; Aflibercept
  • Indications Diabetic macular oedema
  • Focus Registrational; Therapeutic Use
  • Acronyms GLEAM
  • Sponsors Kodiak Sciences

    • Most Recent Events

    • 18 Feb 2024 This trial has been Prematurely Ended in Hungary according to European Clinical Trials Database record.
    • 11 Oct 2023 According to a Kodiak Sciences media release, primary results and new analyses from the Phase 3 GLEAM and GLIMMER studies will be shared at the 56th Annual Scientific Meeting of The Retina Society 2023.
    • 24 Jul 2023 According to a Kodiak Sciences media release, results of this trial will be presented at the 41st Annual Scientific Meeting of the American Society of Retina Specialists

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