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A Phase 2 Randomized, Double-Masked, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Elamipretide in Subjects With Age-Related Macular Degeneration With Non-central Geographic Atrophy

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Trial Profile

A Phase 2 Randomized, Double-Masked, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Elamipretide in Subjects With Age-Related Macular Degeneration With Non-central Geographic Atrophy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 Jul 2024

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At a glance

  • Drugs Elamipretide (Primary)
  • Indications Dry age-related macular degeneration; Dry macular degeneration
  • Focus Therapeutic Use
  • Acronyms RECLAIM-2
  • Sponsors Stealth BioTherapeutics

    • Most Recent Events

    • 04 Dec 2023 According to a Stealth BioTherapeutics media release, the company will participate in a fireside chat at the Baird Biotech Discovery Series on Tuesday, December 5, 2023, at 11:30 AM ET to discuss data from this study.
    • 12 Jun 2023 According to a Stealth BioTherapeutics media release, the company announced the successful and favorable outcomes of an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) for elamipretide for the treatment of dry age-related macular degeneration (AMD).Following the meeting, the FDA's minutes confirmed EZ attenuation as an approvable endpoint in dry AMD.
    • 12 Jun 2023 According to a Stealth BioTherapeutics media release, Results from the ReCLAIM-2 trial in dry AMD were recently presented by Dr. Peter K. Kaiser, from the Cole Eye Institute at the Cleveland Clinic, at the Clinical Trials at the Summit Meeting on June 10, 2023, in Park City, Utah.

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