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Can a daily injection save your sight? new trial for dry AMD

NCT ID NCT06373731

Disease control Sponsor: Stealth BioTherapeutics Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether a daily injection of elamipretide can slow vision loss in people with dry age-related macular degeneration (AMD). About 313 adults aged 55 and older with early dry AMD will receive either the drug or a placebo for 96 weeks. The main goal is to see if the drug reduces the area of damaged retina compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: elamipretide
What this could lead to: If it works, this could slow vision loss from dry AMD, helping people keep their sight longer.
What could go wrong: This is an early look at a new drug; it may not slow vision loss more than a placebo. Daily injections can be uncomfortable and carry infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

313 people

The number who actually took part.

Started

May 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A subject must meet all the inclusion criteria at the Screening and Baseline Visit (unless otherwise specified) to be eligible for inclusion in the trial. 1. Adults ≥ 55 years of age with at least 1 eye with dry AMD with photoreceptor loss, as determined at the Screening Visit by the presence of extrafoveal geographic atrophy (GA), as determined by the Reading Center primarily by fundus autofluorescence (FAF). For this trial, extrafoveal GA is defined as: 1. well-demarcated area(s) of GA 2. All GA lesions must be at least 150 μm from foveal center Note: The fellow eye may have any of the following: no AMD, AMD without GA, AMD with GA, CNV AMD, or foveal GA (ongoing treatment with anti-angiogenic therapies and/or complement inhibitor therapies in the fellow eye is allowable) Ocular conditions - Study Eye: 2. GA in the study eye at the Screening Visit may be multi-focal, but the cumulative GA lesion and size (by FAF, as determined by the Reading Center) must: 1. be ≥ 0.50 mm2 and ≤ 10.16 mm2 AND 2. reside completely within the FAF 30- or 35-degree image 3. BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) score of ≥ 55 letters in the study eye 4. LL BCVA by ETDRS score of ≥ 10 letters in the study eye 5. LLD (defined as the difference between BCVA and LL BCVA) of \> 5 letters in the study eye 6. Sufficiently clear ocular media, adequate pupillary dilation, fixation to permit quality fundus imaging, and ability to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment in the study eye Systemic and General Criteria: 7. Able to administer IMP or have an appropriate designee who can administer the IMP (i.e., a capable family member or a caregiver) 8. Able to provide informed consent and willing to comply with all site visits, examinations, daily IMP administrations and dosing diary entries, and other conditions of the trial protocol 9. Women of childbearing potential must agree to use 1 of the following methods of contraception from the date they sign the ICF until 28 days after the last dose of IMP: 1. Abstinence, when it is in line with the preferred and usual lifestyle of the subject; Subject agrees to use a highly effective method of contraception should they become sexually active 2. Relationships with male partners who have been surgically sterilized by vasectomy (the vasectomy procedure must have been conducted at least 60 days prior to the Screening Visit) 3. Barrier method (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream AND either hormonal contraception (oral, implanted, or injectable) or an intrauterine device or system Note: Non-childbearing potential is defined as surgical sterilization (e.g., bilateral oophorectomy, hysterectomy, or tubal ligation) or postmenopausal (defined as permanent cessation of menstruation for at least 12 consecutive months prior to the Screening Visit). 10. Male subjects with female partners of childbearing potential must be willing to use a highly effective method of contraception (e.g., abstinence, dual method of contraception) from the date they sign the ICF until 28 days after the last dose of IMP Exclusion Criteria: Subjects who meet any of the following criteria at the Screening and Baseline Visit (unless otherwise specified) will be excluded from the trial: Ocular Conditions - Study Eye: 1. The absence of observable hyper-FAF at the margins of the GA in the study eye at the Screening Visit by the Reading Center 2. Atrophic retinal disease of causality other than AMD including myopia-related maculopathy and monogenetic macular dystrophies including pattern dystrophy and adult-onset Stargardt disease in the study eye 3. Evidence of exudative AMD or CNV in the study eye by history or FA , as determined by the Reading Center 4. Presence of retinal vein occlusion in the study eye 5. Presence of vitreous hemorrhage in the study eye 6. History of retinal detachment in the study eye 7. History of macular hole (stages 2 to 4) in the study eye 8. Presence of an epiretinal membrane and/or vitreomacular traction in the study eye that causes distortion of the retinal contour 9. Presence of any retinal pathology in the study eye that prohibits outer retinal quantification and EZ mapping, as determined at the Screening Visit by the Reading Center 10. At the Screening Visit, advanced glaucoma resulting in a cup to disc ratio of \> 0.8 in the study eye 11. History of glaucoma filtration surgery or uncontrolled glaucoma at Baseline Visit in the opinion of the Investigator OR currently using ≥ 3 medications (Minimally invasive glaucoma surgeries (e.g., MIGS) are allowable) Note: Combination medications count as 2 medications. 12. Presence of visually significant cataract OR presence of significant posterior capsular opacity in the setting of pseudophakia Note: Significant cataract is defined as ≥ +3 nuclear sclerosis based upon the scale below or any Posterior Subcapsular Cataract in the study eye. The Sponsor, or its designee, will supply the clinical trial sites with a copy of the standard photographs. Grade Description * 1 Opacity is absent * 2 Opacity is present, but less than Nuclear Standard Photograph #2 * 3 Opacity is present, and as severe as or worse than Nuclear Standard Photograph #2 Source: (Chew 2010) 13. Presence of significant keratopathy or any other media or corneal opacity that would cause scattering of light or alter visual function, especially in LL conditions in the study eye 14. Ocular incisional or laser surgery (including cataract surgery) in the study eye within 90 days before the Baseline Visit 15. YAG laser capsulotomy in the study eye within 30 days before the Baseline Visit 16. Aphakia in the study eye 17. History of vitrectomy surgery, submacular surgery, or any vitreoretinal surgery in the study eye 18. Prior treatment with Visudyne® (verteporfin) ocular photodynamic therapy, external-beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy in the study eye 19. History of subthreshold laser treatment or other forms of photobiomodulation for AMD in the study eye 20. Intravitreal drug delivery in the past 60 days or 5-half-lives from the Baseline Visit of the injected drug whichever is longer (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, or device implantation) in the study eye 21. Intravitreal drug delivery of a complement inhibitor in the past 6 months from the Baseline Visit in the study eye 22. Concurrent disease in the study eye that could require medical or surgical intervention during the trial Ocular conditions - Either Eye: 23. Presence or a history of diabetic retinopathy in either eye (a history of diabetes mellitus without retinopathy is not a criterion for exclusion) 24. History of herpetic infection in either eye 25. Active uveitis and/or vitritis (grade trace or above) in either eye 26. History of idiopathic or autoimmune-associated uveitis in either eye 27. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Systemic Conditions: 28. Has a history of a systemic eosinophilic illness and/or an eosinophil count \>1,000 cells x106/L (equivalent to \>1 cell x 103/μL) at the Screening Visit 29. History of solid organ transplant 30. Any disease or medical condition that in the opinion of the Investigator would prevent the subject from successfully participating in the trial or might confound trial results 31. Current use of medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine \[Plaquenil®\], tamoxifen, phenothiazines, ethambutol, digoxin, and aminoglycosides) 32. eGFR of \< 30 mL/min at the Screening Visit (using the CKD-EPI 2021 formula) General Conditions: 33. Participation in other investigational drug or device clinical trials within 30 days or 5 half-lives (whichever is longer) of Screening; or is currently enrolled in a non-interventional clinical trial that, in the opinion of the Investigator, may be potentially confounding to the results of the current trial 34. Women who are pregnant, planning to become pregnant, or breastfeeding/lactating 35. History of allergy to fluorescein that is not amenable to treatment 36. Inability to comply with trial or follow-up procedures 37. Inability to obtain CFP, FAF, and FA of sufficient quality to be analyzed and interpreted 38. Active malignancy or any other cancer from which the subject has been cancer-free for \< 2 years. Localized squamous or non-invasive basal cell skin carcinomas are allowed, if appropriately treated prior to screening 39. History of allergic reaction to the investigational drug or any of its components 40. Prior participation in any elamipretide trial

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Age related macular degeneration (ARMD)

Contacts and locations

Locations

Associated Retina Consultants

Phoenix, Arizona, 85020, United States
Associated Vitreoretinal and Uveitis Consultants

Carmel, Indiana, 46290, United States
Augenzentrum am St. Franziskus-Hospital

Münster, Germany
Austin Clinical Research, LLC

Austin, Texas, 78750, United States
Axon Clinical, s.r.o.

Prague, Czechia
Barnet Dulaney Perkins Eye Center

Sun City, Arizona, 85351, United States
Bay Area Retina Associates

Walnut Creek, California, 94598, United States
Capital Eye Specialists

Wellington, 6011, New Zealand
Centro de Oftalmologia Barraquer

Barcelona, Spain
Connecticut Eye Consultants, P.C.

Danbury, Connecticut, 06810, United States
Department für Augenheilkunde

Tübingen, Germany
Department of Ophthalmology, Azienda SanitariaUniversitaria Friuli Centrale

Udine, Italy
Emerson Clinical Research Institute

Falls Church, Virginia, 22042, United States
Florida Retina Institute

Orlando, Florida, 32806, United States
Fondazione Policlinico Gemelli

Roma, Italy
Fundacion Aiken de la Comunitat Valenciana

Valencia, Spain
Ganglion Medical Center

Pécs, Hungary
Hospital Luigi Sacco Ophthalmology Dept

Milan, Italy
IRRCS Ospendale San Raffaele

Milan, Italy
Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States
Klinik und Poliklinik für Augenheilkunde- Universitätsklinik Regensburg

Regensburg, Germany
Macular Services, Central Middlesex Hospital, NHS Foundation Trust

London, United Kingdom
Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States
Mid Atlantic Retina

Cherry Hill, New Jersey, 08034, United States
Mid Atlantic Retina Specialist

Hagerstown, Maryland, 21740, United States
NJ Retina

Teaneck, New Jersey, 07666, United States
OMIQ Research

Barcelona, Spain
Oftalvist

Valencia, Spain
Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States
Orange County Retinal Medical Group

Santa Ana, California, 92705, United States
Pacific Northwest Retina, PLLC

Silverdale, Washington, 98383, United States
Policlinico Milano

Milan, Italy
Retina Associates of Southern California

Huntington Beach, California, 92607, United States
Retina Consultants of Minnesota

Minneapolis, Minnesota, 55435, United States
Retina Consultants of San Diego

Poway, California, 92064, United States
Retina Consultants of Southern Colorado

Colorado Springs, Colorado, 80909, United States
Retina Consultants of Texas

Bellaire, Texas, 77401, United States
Retina Consultants of Texas

The Woodlands, Texas, 77384, United States
Retina Northwest, PC

Portland, Oregon, 97221, United States
Retina Research Institute of Texas

Abilene, Texas, 79606, United States
Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States
Retina Vitreous Center

Edmond, Oklahoma, 73013, United States
Retinal Consultants Medical Group

Sacramento, California, 95825, United States
South Tyneside and Sunderland NHS Foundation Trust - Sunderland Eye Infirmary

Sunderland, United Kingdom
Southern Eye Specialists

Christchurch, 8013, New Zealand
Texas Retina Associates of Plano

Plano, Texas, 75075, United States
University Hospitals Bristol NHS Foundation Trust - Bristol Eye Hospital

Bristol, United Kingdom
University Hospitals of Leicester, Leicester Royal Infirmary

Leicester, United Kingdom
University Of Debrecen Eye Center

Debrecen, Hungary
University Retina and Macula Associates

Oak Forest, Illinois, 60452, United States
University of Szeged, Department of Ophthalmology

Szeged, Hungary
Valley Retina Institute

McAllen, Texas, 78503, United States
Vitreo Retinal Associates

Gainesville, Florida, 32607, United States

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