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ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)
NCT06373731 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06373731
The ClinicalTrials.gov registry entry for NCT06373731 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 313 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stealth BioTherapeutics, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06373731 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06373731?
The interventions under investigation include: Placebo (DRUG), Elamipretide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06373731?
This trial is sponsored by Stealth BioTherapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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