Clinical Trial

ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

Study acronym: ReNEW
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared.
Protocol Amendment History 44 amendments
This ClinicalTrials.gov record has been amended 44 times since 2024-04-16; most recent amendment 2026-05-18.
Status change: Recruiting → Active, Not Recruiting 2025-10-22
Status change: Not Yet Recruiting → Recruiting 2024-05-13
Trial Details
NCT Number NCT06373731
Lead Sponsor Stealth BioTherapeutics Inc.
Conditions Age Related Macular Degeneration (ARMD)
Enrollment 313 participants
Start Date 2024-05-30
Primary Completion 2027-08 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-20