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NCT06373731 · ClinicalTrials.gov registry record · Phase 3
ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)
A Phase 3 study of Age Related Macular Degeneration (ARMD), sponsored by Stealth BioTherapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 313
- Enrollment target
- 20
- Study locations
NCT06373731: Active Phase 3 study of Age Related Macular Degeneration (ARMD), sponsored by Stealth BioTherapeutics.
NCT06373731 is a Phase 3 study of Age Related Macular Degeneration (ARMD) that is active but no longer recruiting, run by Stealth BioTherapeutics. The registered enrollment target is 313 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06373731, a Phase 3 study of Age Related Macular Degeneration (ARMD), is active but no longer recruiting, sponsored by Stealth BioTherapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 313 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Rate of change in the macular area of photoreceptor loss (defined as an EZ-RPE thickness of 0μm) assessed by SD-OCT and EZ mapping at Week 48
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Elamipretide
Study Locations (20)
California
- Retina Associates of Southern California - Huntington Beach
- Retina Consultants of San Diego - Poway
- Retinal Consultants Medical Group - Sacramento
- Orange County Retinal Medical Group - Santa Ana
- Bay Area Retina Associates - Walnut Creek
Florida
- Vitreo Retinal Associates - Gainesville
- Florida Retina Institute - Orlando
- Retina Vitreous Associates of Florida - St. Petersburg
Arizona
- Associated Retina Consultants - Phoenix
- Barnet Dulaney Perkins Eye Center - Sun City
New Jersey
- Mid Atlantic Retina - Cherry Hill
- NJ Retina - Teaneck
Colorado
- Retina Consultants of Southern Colorado - Colorado Springs
Connecticut
- Connecticut Eye Consultants, P.C. - Danbury
Illinois
- University Retina and Macula Associates - Oak Forest
Indiana
- Associated Vitreoretinal and Uveitis Consultants - Carmel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2024-05-30 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
What the registry record for NCT06373731 still lists
NCT06373731 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Age Related Macular Degeneration (ARMD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06373731 names 20 study sites across 12 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06373731 about?
NCT06373731 is a clinical study titled "ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)". 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...
What is the current status of trial NCT06373731?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 313 participants. The study started on 2024-05-30. Estimated completion is 2027-09.
What conditions does trial NCT06373731 study?
This clinical trial studies the following conditions: Age Related Macular Degeneration (ARMD).
What interventions are being tested in trial NCT06373731?
The interventions under investigation include: Placebo (DRUG), Elamipretide (DRUG).
Who is sponsoring clinical trial NCT06373731?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06373731 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Age Related Macular Degeneration (ARMD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06373731's enrollment target sits among peer trials
313 1101st of 2000 higher than 899 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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