AzTrials
AzTrials

Age Related Macular Degeneration (ARMD)Phase 3ReNEWNCT06373731

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 testing Elamipretide in people with Age Related Macular Degeneration (ARMD), run by Stealth BioTherapeutics Inc. at 53 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Age Related Macular Degeneration (ARMD)
What is being tested?
Elamipretide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
313 participants
Where
53 sitesin 8 countries
Study dates
30 May 2024to Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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:
  • well-demarcated area(s) of GA
  • 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:
  • 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:
Show all 20Show fewer
  • be ≥ 0.50 mm2 and ≤ 10.16 mm2 AND
  • reside completely within the FAF 30- or 35-degree image
  • BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) score of ≥ 55 letters in the study eye
  • LL BCVA by ETDRS score of ≥ 10 letters in the study eye
  • LLD (defined as the difference between BCVA and LL BCVA) of > 5 letters in the study eye
  • 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:
  • Able to administer IMP or have an appropriate designee who can administer the IMP (i.e., a capable family member or a caregiver)
  • 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
  • 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:
  • 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
  • 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)
  • 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).
  • 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

Who cannot join

  • 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:
  • The absence of observable hyper-FAF at the margins of the GA in the study eye at the Screening Visit by the Reading Center
  • 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
  • Evidence of exudative AMD or CNV in the study eye by history or FA , as determined by the Reading Center
  • Presence of retinal vein occlusion in the study eye
Show all 48Show fewer
  • Presence of vitreous hemorrhage in the study eye
  • History of retinal detachment in the study eye
  • History of macular hole (stages 2 to 4) in the study eye
  • Presence of an epiretinal membrane and/or vitreomacular traction in the study eye that causes distortion of the retinal contour
  • 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
  • At the Screening Visit, advanced glaucoma resulting in a cup to disc ratio of > 0.8 in the study eye
  • 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.
  • 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)
  • 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
  • Ocular incisional or laser surgery (including cataract surgery) in the study eye within 90 days before the Baseline Visit
  • YAG laser capsulotomy in the study eye within 30 days before the Baseline Visit
  • Aphakia in the study eye
  • History of vitrectomy surgery, submacular surgery, or any vitreoretinal surgery in the study eye
  • Prior treatment with Visudyne® (verteporfin) ocular photodynamic therapy, external-beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy in the study eye
  • History of subthreshold laser treatment or other forms of photobiomodulation for AMD in the study eye
  • 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
  • Intravitreal drug delivery of a complement inhibitor in the past 6 months from the Baseline Visit in the study eye
  • Concurrent disease in the study eye that could require medical or surgical intervention during the trial
  • Ocular conditions - Either Eye:
  • Presence or a history of diabetic retinopathy in either eye (a history of diabetes mellitus without retinopathy is not a criterion for exclusion)
  • History of herpetic infection in either eye
  • Active uveitis and/or vitritis (grade trace or above) in either eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Systemic Conditions:
  • 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
  • History of solid organ transplant
  • 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
  • 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)
  • eGFR of < 30 mL/min at the Screening Visit (using the CKD-EPI 2021 formula)
  • General Conditions:
  • 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
  • Women who are pregnant, planning to become pregnant, or breastfeeding/lactating
  • History of allergy to fluorescein that is not amenable to treatment
  • Inability to comply with trial or follow-up procedures
  • Inability to obtain CFP, FAF, and FA of sufficient quality to be analyzed and interpreted
  • 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
  • History of allergic reaction to the investigational drug or any of its components
  • Prior participation in any elamipretide trial

Trial locations and contacts

53 sites in 8 countries.

53 sites in 8 countries

United States31 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Kellogg Eye Center

    Ann Arbor, Michigan, 48105

  • Austin Clinical Research, LLC

    Austin, Texas, 78750

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Associated Vitreoretinal and Uveitis Consultants

    Carmel, Indiana, 46290

  • Mid Atlantic Retina

    Cherry Hill, New Jersey, 08034

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

  • Connecticut Eye Consultants, P.C.

    Danbury, Connecticut, 06810

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013

  • Emerson Clinical Research Institute

    Falls Church, Virginia, 22042

  • Vitreo Retinal Associates

    Gainesville, Florida, 32607

  • Mid Atlantic Retina Specialist

    Hagerstown, Maryland, 21740

  • Retina Associates of Southern California

    Huntington Beach, California, 92607

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Retina Consultants of Minnesota

    Minneapolis, Minnesota, 55435

  • University Retina and Macula Associates

    Oak Forest, Illinois, 60452

  • Florida Retina Institute

    Orlando, Florida, 32806

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Texas Retina Associates of Plano

    Plano, Texas, 75075

  • Retina Northwest, PC

    Portland, Oregon, 97221

  • Retina Consultants of San Diego

    Poway, California, 92064

  • Retinal Consultants Medical Group

    Sacramento, California, 95825

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Orange County Retinal Medical Group

    Santa Ana, California, 92705

  • Pacific Northwest Retina, PLLC

    Silverdale, Washington, 98383

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711

  • Barnet Dulaney Perkins Eye Center

    Sun City, Arizona, 85351

  • NJ Retina

    Teaneck, New Jersey, 07666

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

Other trials in United States

Italy5 sites

  • Hospital Luigi Sacco Ophthalmology Dept

    Milan

  • IRRCS Ospendale San Raffaele

    Milan

  • Policlinico Milano

    Milan

  • Fondazione Policlinico Gemelli

    Roma

  • Department of Ophthalmology, Azienda SanitariaUniversitaria Friuli Centrale

    Udine

Other trials in Italy

Spain4 sites

  • Centro de Oftalmologia Barraquer

    Barcelona

  • OMIQ Research

    Barcelona

  • Fundacion Aiken de la Comunitat Valenciana

    Valencia

  • Oftalvist

    Valencia

Other trials in Spain

United Kingdom4 sites

  • University Hospitals Bristol NHS Foundation Trust - Bristol Eye Hospital

    Bristol

  • University Hospitals of Leicester, Leicester Royal Infirmary

    Leicester

  • Macular Services, Central Middlesex Hospital, NHS Foundation Trust

    London

  • South Tyneside and Sunderland NHS Foundation Trust - Sunderland Eye Infirmary

    Sunderland

Other trials in United Kingdom

Germany3 sites

  • Augenzentrum am St. Franziskus-Hospital

    Münster

  • Klinik und Poliklinik für Augenheilkunde- Universitätsklinik Regensburg

    Regensburg

  • Department für Augenheilkunde

    Tübingen

Other trials in Germany

Hungary3 sites

  • University Of Debrecen Eye Center

    Debrecen

  • Ganglion Medical Center

    Pécs

  • University of Szeged, Department of Ophthalmology

    Szeged

Other trials in Hungary

New Zealand2 sites

  • Southern Eye Specialists

    Christchurch, 8013

  • Capital Eye Specialists

    Wellington, 6011

Other trials in New Zealand

Czechia1 site

  • Axon Clinical, s.r.o.

    Prague

Other trials in Czechia

About this study

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)

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.

Read the detailed description

The ReNEW (SPIAM-301) trial is a phase 3, randomized, double-masked, parallel-group, placebo-controlled clinical trial to evaluate the efficacy, safety, and pharmacokinetics of a once daily subcutaneous (SC) injection of elamipretide in subjects who have dry AMD. Subjects will be randomized (2:1) to once daily SC doses of 40 mg elamipretide, or placebo for 96 weeks of treatment by a central randomization and stratified by SD-OCT device type (Heidelberg SPECTRALIS®, ZEISS CIRRUS®) and baseline macular area of photoreceptor loss, defined as an ellipsoid zone-retinal pigment epithelium (EZ-RPE) thickness of 0μm assessed by SD-OCT and ellipsoid zone (EZ) mapping (High Strata ≥ 5.1mm2, Low Strata <5.1mm2).

Primary Objective

  • Evaluate the efficacy of once daily subcutaneous (SC) injections of elamipretide in subjects who have dry age-related macular degeneration (AMD) Secondary Objectives
  • Evaluate the safety and tolerability of once daily SC injections of elamipretide
  • Evaluate the Pharmacokinetic (PK) profile of elamipretide and its metabolites
Being tested
Elamipretide, Placebo
Keywords
dAMD, Dry AMD, dryAMD, Macular degeneration, non-central geographic atrophy, GA, MTP-131, elamipretide, Non- Intravitreal, Non- gene therapy
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElamipretideDrug

    Also called Elamipretide HCL

    Subjects will receive once daily SC doses of 40 mg elamipretide for 96 weeks

  • PlaceboDrug

    Subjects will receive once daily SC doses of Placebo 96 weeks

Study groups in NCT06373731
Study groupRoleWhat they receive
ElamipretideExperimentalSubjects will receive once daily subcutaneous doses of 40mg elamipretide for 96 weeks
Receives: Drug: Elamipretide
PlaceboPlacebo comparatorSubjects will receive once daily subcutaneous doses of placebo for 96 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Week 48 Rate of change in the macular area of photoreceptor loss

    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

    Measured: Baseline, Week 48

Secondary outcomes (4)

  1. Week 72 Rate of change in the Macular area of photoreceptor loss

    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 72

    Measured: Baseline, Week 72

  2. Week 96 Rate of change in the Macular area of photoreceptor loss

    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

    Measured: Baseline, Week 96

  3. Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best-Corrected Visual Acuity (LL BCVA)

    Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best- Corrected Visual Acuity (LL BCVA) from baseline at Week 48

    Measured: Baseline, Week 48

  4. Proportion of subjects gaining ≥ 15 letters in Low Luminance Best-Corrected Visual Acuity (LL BCVA)

    Proportion of subjects gaining ≥ 15 letters (3 lines) in LL BCVA from baseline at Week 48

    Measured: Baseline, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start30 May 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized (2:1) to once daily 40 mg SC of elamipretide or placebo for 96 weeks of treatment by a central randomization
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06373731
Sponsor's protocol ID
SPIAM-301
Acronym
ReNEW
Status last verified
Sep 2026
First submitted
16 Apr 2024
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elamipretide in people with Age Related Macular Degeneration (ARMD), run by Stealth BioTherapeutics Inc. at 53 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Italy, Spain, United Kingdom, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Week 48 Rate of change in the macular area of photoreceptor loss (time frame: Baseline, Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06373731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in