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A Multi-Center, Randomized, Parallel-Group, Phase 2, Masked, Three-Arm Trial to Compare Safety, Tolerability, Efficacy, and Durability of Two Dose Levels of Suprachoroidal Sustained-Release OXU-001 (Dexamethasone Microspheres; DEXAspheres®) Using the Oxulumis® Illuminated Microcatheterization Device Compared With Intravitreal Dexamethasone Implant (OZURDEX®) in Subjects With Diabetic Macular Edema (OXEYE)

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Trial Profile

A Multi-Center, Randomized, Parallel-Group, Phase 2, Masked, Three-Arm Trial to Compare Safety, Tolerability, Efficacy, and Durability of Two Dose Levels of Suprachoroidal Sustained-Release OXU-001 (Dexamethasone Microspheres; DEXAspheres®) Using the Oxulumis® Illuminated Microcatheterization Device Compared With Intravitreal Dexamethasone Implant (OZURDEX®) in Subjects With Diabetic Macular Edema (OXEYE)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Feb 2024

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At a glance

  • Drugs Dexamethasone (Primary) ; Dexamethasone
  • Indications Diabetic macular oedema
  • Focus Adverse reactions
  • Acronyms OXEYE
  • Sponsors Oxular
  • Most Recent Events

    • 12 Feb 2024 Planned primary completion date changed from 1 Sep 2024 to 30 Nov 2024.
    • 12 Feb 2024 Status changed from recruiting to active, no longer recruiting.
    • 24 Oct 2023 According to Oxular media release, company expects to report 24-week data from Part A, including safety and durability, in the second half of 2024.
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