Trial Profile

ReNEW: A Phase 3, Double-Masked, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects Who Have Dry Age-Related Macular Degeneration (Dry AMD)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 08 Jun 2025

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At a glance

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 announced that it has achieved its 50 percent enrollment target in this global Phase 3 ReNEW study.Data from the ReNEW study is expected to be reported in 2026.
13 May 2024 Status changed from not yet recruiting to recruiting.

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