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NCT06373731 | RECRUITING | Age Related Macular Degeneration (ARMD)

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

Stealth BioTherapeutics Inc.

Brief 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.

Condition or disease

Age Related Macular Degeneration (ARMD)

Intervention/treatment

Elamipretide

Placebo

Phase

PHASE3

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 360 participants
Masking : QUADRUPLE
Masking Description : Trial personnel and subjects will be masked to treatment until the database is locked at the end of the trial, unless noted below. The Investigator will contact the Sponsor Medical Monitor prior to unmasking any subject's treatment sequence unless in the instance of a medical emergency. In case of an immediate medical emergency, or if directed by the Sponsor, and only if the information is required by the Investigator to manage a subject's AE, a subject's treatment assignment may be unmasked prematurely using the computerized system. The Sponsor must be notified as soon as possible regarding the reason for unmasking.
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-05-30
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2027-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

Location Details

NCT06373731

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Associated Retina Consultants

Phoenix, Arizona, United States, 85020

ACTIVE NOT RECRUITING

United States, Arizona

Burnett Dulne Perkins Oy Center

Sun City, Arizona, United States, 85351

RECRUITING

United States, California

Retina Associates of Southern California

Huntington Beach, California, United States, 92607

RECRUITING

United States, California

Retina Consultants of San Diego

Poway, California, United States, 92064

RECRUITING

United States, California

Retinal Consultants Medical Group

Sacramento, California, United States, 95825

RECRUITING

United States, California

Orange County Retinal Medical Group

Santa Anna, California, United States, 92705

RECRUITING

United States, California

Bay Area Retina Associates

Walnut Creek, California, United States, 94598

RECRUITING

United States, Colorado

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, United States, 80909

RECRUITING

United States, Connecticut

Connecticut Eye Consultants, P.C.

Danbury, Connecticut, United States, 06810

RECRUITING

United States, Florida

Blue Ocean Clinical Research Center

Clearwater, Florida, United States, 33761

RECRUITING

United States, Florida

Vitreo Retinal Associates

Gainesville, Florida, United States, 32607

RECRUITING

United States, Florida

Florida Retina Institute

Orlando, Florida, United States, 32806

RECRUITING

United States, Florida

Retina Vitreous Associates of Florida

Saint Petersburg, Florida, United States, 33711

RECRUITING

United States, Illinois

University Retina and Macula Associates

Oak Forest, Illinois, United States, 60452

RECRUITING

United States, Indiana

Associated Vitreoretinal and Uveitis Consultants

Carmel, Indiana, United States, 46290

RECRUITING

United States, Maryland

Mid Atlantic Retina Specialist

Hagerstown, Maryland, United States, 21740

RECRUITING

United States, Massachusetts

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Road cancer

Kellogg Eye Center

Ann Arbor, Road cancer, United States, 48105

RECRUITING

United States, Minnesota

Retina Consultants of Minnesota

Minneapolis, Minnesota, United States, 55435

RECRUITING

United States, New Jersey

Mid Atlantic Retina

Cherry Hill, New Jersey, United States, 08034

RECRUITING

United States, New Jersey

Nj retina

Teaneck, New Jersey, United States, 07666

WITHDRAWN

United States, Ohio

MidWest Eye Center

Cincinnati, Ohio, United States, 45202

RECRUITING

United States, Oklahola

Retina Vitreous Center

Edmond, Okholohan, United States, 73013

RECRUITING

United States, Oregon

Retina Northwest, PC

Portland, Oregon, United States, 97221

RECRUITING

United States, Texas

Retina Research Institute of Texas

Abilene, Texas, United States, 79606

RECRUITING

United States, Texas

Austin Clinical Research, LLC

Austin, Texas, United States, 78750

RECRUITING

United States, Texas

Retina Consultants of Texas

Bellaire, Texas, United States, 77401

RECRUITING

United States, Texas

Valley Retina Institute

McAllen, Texas, United States, 78503

RECRUITING

United States, Texas

Texas Retina Associates of Plano

Plano, Texas, United States, 75075

RECRUITING

United States, Texas

Medical Center Ophthalmology Associates

San Antonio, Texas, United States, 78240

RECRUITING

United States, Texas

Retina Consultants of Texas

The Woodlands, Texas, United States, 77384

RECRUITING

United States, Virginia

Emerson Clinical Research Institute

Falls Church, Virginia, United States, 22042

RECRUITING

United States, Virginia

Wagner Kapoor Research Institute

Norfolk, Virginia, United States, 23502

RECRUITING

United States, Washington

Pacific Northwest Retina, PLLC

Silverdale, Washington, United States, 98383

RECRUITING

Czechia,

Oftex Eye Clinic

Pardubice, Czechia,

RECRUITING

Czechia,

Axon Clinical, s.r.o.

Prague, Czechia,

RECRUITING

Czechia,

Ocni Clinic

Prague, Czechia,

RECRUITING

Germany,

University eye clinic

Bonn, Germany,

RECRUITING

Germany,

Clinic for Ophthalmology, UKSH Kiel

As, Germany,

RECRUITING

Germany,

Eye center at the St. Franziskus Hospital

Münster, Germany,

RECRUITING

Germany,

Clinic and polyclinic for ophthalmology university clinic Regensburg

Regensburg, Germany,

RECRUITING

Germany,

Department of ophthalmology

Tübingen, Germany,

RECRUITING

Hungary,

University Of Debrecen Eye Center

Debrecen, Hungary,

RECRUITING

Hungary,

Ganglion Medical Center

Pécs, Hungary,

RECRUITING

Hungary,

University of Szeged, Department of Ophthalmology

Szeged, Hungary,

RECRUITING

Italy,

Hospital Luigi Sacco Ophthalmology Dept

Milano, Italy,

RECRUITING

Italy,

IRRCS Ospendale San Raffaele

Milano, Italy,

RECRUITING

Italy,

Polyclinic Milan

Milano, Italy,

RECRUITING

Italy,

Gemelli Polyclinic Foundation

Roma, Italy,

RECRUITING

Italy,

Department of Ophthalmology, Friuli Centrale University Health Authority

Udine, Italy,

RECRUITING

New Zealand,

Southern Eye Specialists

Christchurch, New Zealand, 8013

RECRUITING

New Zealand,

Capital Eye Specialists

Wellington, New Zealand, 6011

RECRUITING

Spain,

Barraquer ophthalmology center

Barcelona, Spain,

RECRUITING

Spain,

OMIQ Research

Barcelona, Spain,

RECRUITING

Spain,

Aiken Foundation of the Valencian Community

Valencia, Spain,

RECRUITING

Spain,

Oftalvist

Valencia, Spain,

RECRUITING

United Kingdom,

University Hospitals Bristol NHS Foundation Trust - Bristol Eye Hospital

Bristol, United Kingdom,

RECRUITING

United Kingdom,

University Hospitals of Leicester, Leicester Royal Infirmary

Leicester, United Kingdom,

RECRUITING

United Kingdom,

Macular Services, Central Middlesex Hospital, NHS Foundation Trust

London, United Kingdom,

RECRUITING

United Kingdom,

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom,

RECRUITING

United Kingdom,

Salisbury NHS Foundation Trust

Salisbury, United Kingdom,

RECRUITING

United Kingdom,

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom,

RECRUITING

United Kingdom,

South Tyneside and Sunderland NHS Foundation Trust - Sunderland Eye Infirmary

Sunderland, United Kingdom,