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A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 µg/day and ASI-001B 0.2 µg/day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects with Diabetic Macular Edema

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Trial Profile

A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 µg/day and ASI-001B 0.2 µg/day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects with Diabetic Macular Edema

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Feb 2024

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At a glance

  • Drugs Fluocinolone acetonide (Primary)
  • Indications Diabetic macular oedema
  • Focus Registrational; Therapeutic Use
  • Acronyms FAME
  • Sponsors Alimera Sciences
  • Most Recent Events

    • 08 Feb 2024 According to an Alimera Sciences media release, the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending that patients with a natural lens (phakic patients) being treated for chronic diabetic macular edema (DME) have access to ILUVIEN 190 microgram intravitreal implant in applicator (fluocinolone acetonide).
    • 11 Jul 2018 According to an Alimera Sciences media release, data from this study will be presented at the 36th Annual Meeting of the American Society of Retina Specialists (ASRS) 2018.
    • 28 Mar 2018 According to an EyePoint Pharmaceuticals media release, pSivida Corp. changed its name to EyePoint Pharmaceuticals.
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