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A phase 3 study evaluating the efficacy and safety of once-daily self-administered subcutaneous injections of elamipretide in participants with dry age-related macular degeneration(dry AMD)

Trial Profile

A phase 3 study evaluating the efficacy and safety of once-daily self-administered subcutaneous injections of elamipretide in participants with dry age-related macular degeneration(dry AMD)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2025

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At a glance

  • Drugs Elamipretide (Primary)
  • Indications Dry age-related macular degeneration
  • Focus Therapeutic Use
  • Acronyms ReGAIN study
  • Most Recent Events

    • 18 Mar 2025 New trial record
    • 13 Mar 2025 According to a Stealth BioTherapeutics, In the ReNEW and ReGAIN trials, 360 patients will be randomized 2:1 to either elamipretide or placebo for 96 weeks with the option for participants to enroll in the open-label extension trial, ReTAIN.
    • 13 Mar 2025 According to a Stealth BioTherapeutics media release, the company will initiate the ReGAIN study in 2025.

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