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

PHASE3RecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

May 30, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2027

Conditions
Age Related Macular Degeneration (ARMD)
Interventions
DRUG

Elamipretide

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

DRUG

Placebo

Subjects will receive once daily SC doses of Placebo 96 weeks

Trial Locations (63)

6011

RECRUITING

Capital Eye Specialists, Wellington

8013

RECRUITING

Southern Eye Specialists, Christchurch

21740

RECRUITING

Mid Atlantic Retina Specialist, Hagerstown

22042

RECRUITING

Emerson Clinical Research Institute, Falls Church

23502

RECRUITING

Wagner Kapoor Research Institute, Norfolk

32607

RECRUITING

Vitreo Retinal Associates, Gainesville

32806

RECRUITING

Florida Retina Institute, Orlando

33711

RECRUITING

Retina Vitreous Associates of Florida, St. Petersburg

33761

WITHDRAWN

Blue Ocean Clinical Research Center, Clearwater

45202

WITHDRAWN

MidWest Eye Center, Cincinnati

46290

RECRUITING

Associated Vitreoretinal and Uveitis Consultants, Carmel

48105

RECRUITING

Kellogg Eye Center, Ann Arbor

55435

RECRUITING

Retina Consultants of Minnesota, Minneapolis

60452

RECRUITING

University Retina and Macula Associates, Oak Forest

73013

RECRUITING

Retina Vitreous Center, Edmond

75075

RECRUITING

Texas Retina Associates of Plano, Plano

77384

RECRUITING

Retina Consultants of Texas, The Woodlands

77401

RECRUITING

Retina Consultants of Texas, Bellaire

78240

RECRUITING

Medical Center Ophthalmology Associates, San Antonio

78503

RECRUITING

Valley Retina Institute, McAllen

78750

RECRUITING

Austin Clinical Research, LLC, Austin

79606

RECRUITING

Retina Research Institute of Texas, Abilene

80909

RECRUITING

Retina Consultants of Southern Colorado, Colorado Springs

85020

RECRUITING

Associated Retina Consultants, Phoenix

85351

ACTIVE_NOT_RECRUITING

Barnet Dulaney Perkins Eye Center, Sun City

92064

RECRUITING

Retina Consultants of San Diego, Poway

92607

RECRUITING

Retina Associates of Southern California, Huntington Beach

92705

RECRUITING

Orange County Retinal Medical Group, Santa Ana

94598

RECRUITING

Bay Area Retina Associates, Walnut Creek

95825

RECRUITING

Retinal Consultants Medical Group, Sacramento

97221

RECRUITING

Retina Northwest, PC, Portland

98383

RECRUITING

Pacific Northwest Retina, PLLC, Silverdale

06810

RECRUITING

Connecticut Eye Consultants, P.C., Danbury

02114

RECRUITING

Ophthalmic Consultants of Boston, Boston

08034

RECRUITING

Mid Atlantic Retina, Cherry Hill

07666

RECRUITING

NJ Retina, Teaneck

Unknown

RECRUITING

Oftex Eye Clinic, Pardubice

RECRUITING

Axon Clinical, s.r.o., Prague

WITHDRAWN

Ocni klinika, Prague

RECRUITING

Universitäts-Augenklinik, Bonn

RECRUITING

Klinik für Ophthalmologie, UKSH Kiel, Kiel

RECRUITING

Augenzentrum am St. Franziskus-Hospital, Münster

RECRUITING

Klinik und Poliklinik für Augenheilkunde- Universitätsklinik Regensburg, Regensburg

RECRUITING

Department für Augenheilkunde, Tübingen

RECRUITING

University Of Debrecen Eye Center, Debrecen

RECRUITING

Ganglion Medical Center, Pécs

RECRUITING

University of Szeged, Department of Ophthalmology, Szeged

RECRUITING

Hospital Luigi Sacco Ophthalmology Dept, Milan

RECRUITING

IRRCS Ospendale San Raffaele, Milan

RECRUITING

Policlinico Milano, Milan

RECRUITING

Fondazione Policlinico Gemelli, Roma

RECRUITING

Department of Ophthalmology, Azienda SanitariaUniversitaria Friuli Centrale, Udine

RECRUITING

Centro de Oftalmologia Barraquer, Barcelona

RECRUITING

OMIQ Research, Barcelona

RECRUITING

Fundacion Aiken de la Comunitat Valenciana, Valencia

RECRUITING

Oftalvist, Valencia

RECRUITING

University Hospitals Bristol NHS Foundation Trust - Bristol Eye Hospital, Bristol

RECRUITING

University Hospitals of Leicester, Leicester Royal Infirmary, Leicester

RECRUITING

Macular Services, Central Middlesex Hospital, NHS Foundation Trust, London

RECRUITING

Moorfields Eye Hospital NHS Foundation Trust, London

RECRUITING

Salisbury NHS Foundation Trust, Salisbury

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

RECRUITING

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

All Listed Sponsors
lead

Stealth BioTherapeutics Inc.

INDUSTRY

NCT06373731 - ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) | Biotech Hunter | Biotech Hunter