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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06373731

Public ClinicalTrials.gov record NCT06373731. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 9:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06373731
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Enrollment
313 participants

Conditions and interventions

Eligibility (public fields only)

Age range
55 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 30, 2024 (Actual)
Primary completion
Aug 2027 (Estimated)
Completion
Sep 2027 (Estimated)
Last update posted
Sep 17, 2026

2024 – 2027

United States locations

U.S. sites
31
U.S. states
17
U.S. cities
31
Facility City State ZIP Site status
Associated Retina Consultants Phoenix Arizona 85020 —
Barnet Dulaney Perkins Eye Center Sun City Arizona 85351 —
Retina Associates of Southern California Huntington Beach California 92607 —
Retina Consultants of San Diego Poway California 92064 —
Retinal Consultants Medical Group Sacramento California 95825 —
Orange County Retinal Medical Group Santa Ana California 92705 —
Bay Area Retina Associates Walnut Creek California 94598 —
Retina Consultants of Southern Colorado Colorado Springs Colorado 80909 —
Connecticut Eye Consultants, P.C. Danbury Connecticut 06810 —
Vitreo Retinal Associates Gainesville Florida 32607 —
Florida Retina Institute Orlando Florida 32806 —
Retina Vitreous Associates of Florida St. Petersburg Florida 33711 —
University Retina and Macula Associates Oak Forest Illinois 60452 —
Associated Vitreoretinal and Uveitis Consultants Carmel Indiana 46290 —
Mid Atlantic Retina Specialist Hagerstown Maryland 21740 —
Ophthalmic Consultants of Boston Boston Massachusetts 02114 —
Kellogg Eye Center Ann Arbor Michigan 48105 —
Retina Consultants of Minnesota Minneapolis Minnesota 55435 —
Mid Atlantic Retina Cherry Hill New Jersey 08034 —
NJ Retina Teaneck New Jersey 07666 —
Retina Vitreous Center Edmond Oklahoma 73013 —
Retina Northwest, PC Portland Oregon 97221 —
Retina Research Institute of Texas Abilene Texas 79606 —
Austin Clinical Research, LLC Austin Texas 78750 —
Retina Consultants of Texas Bellaire Texas 77401 —
Valley Retina Institute McAllen Texas 78503 —
Texas Retina Associates of Plano Plano Texas 75075 —
Medical Center Ophthalmology Associates San Antonio Texas 78240 —
Retina Consultants of Texas The Woodlands Texas 77384 —
Emerson Clinical Research Institute Falls Church Virginia 22042 —
Pacific Northwest Retina, PLLC Silverdale Washington 98383 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06373731, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 17, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06373731 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →