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)

Status: Active_not_recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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:

∙ 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

Locations
United States
Arizona
Associated Retina Consultants
Phoenix
Barnet Dulaney Perkins Eye Center
Sun City
California
Retina Associates of Southern California
Huntington Beach
Retina Consultants of San Diego
Poway
Retinal Consultants Medical Group
Sacramento
Orange County Retinal Medical Group
Santa Ana
Bay Area Retina Associates
Walnut Creek
Colorado
Retina Consultants of Southern Colorado
Colorado Springs
Connecticut
Connecticut Eye Consultants, P.C.
Danbury
Florida
Vitreo Retinal Associates
Gainesville
Florida Retina Institute
Orlando
Retina Vitreous Associates of Florida
St. Petersburg
Illinois
University Retina and Macula Associates
Oak Forest
Indiana
Associated Vitreoretinal and Uveitis Consultants
Carmel
Massachusetts
Ophthalmic Consultants of Boston
Boston
Maryland
Mid Atlantic Retina Specialist
Hagerstown
Michigan
Kellogg Eye Center
Ann Arbor
Minnesota
Retina Consultants of Minnesota
Minneapolis
New Jersey
Mid Atlantic Retina
Cherry Hill
NJ Retina
Teaneck
Oklahoma
Retina Vitreous Center
Edmond
Oregon
Retina Northwest, PC
Portland
Texas
Retina Research Institute of Texas
Abilene
Austin Clinical Research, LLC
Austin
Retina Consultants of Texas
Bellaire
Valley Retina Institute
Mcallen
Texas Retina Associates of Plano
Plano
Medical Center Ophthalmology Associates
San Antonio
Retina Consultants of Texas
The Woodlands
Virginia
Emerson Clinical Research Institute
Falls Church
Washington
Pacific Northwest Retina, PLLC
Silverdale
Other Locations
Germany
Augenzentrum am St. Franziskus-Hospital
Münster
Klinik und Poliklinik für Augenheilkunde- Universitätsklinik Regensburg
Regensburg
Department für Augenheilkunde
Tübingen
Hungary
University Of Debrecen Eye Center
Debrecen
Ganglion Medical Center
Pécs
University of Szeged, Department of Ophthalmology
Szeged
Italy
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
New Zealand
Southern Eye Specialists
Christchurch
Capital Eye Specialists
Wellington
Spain
Centro de Oftalmologia Barraquer
Barcelona
OMIQ Research
Barcelona
Fundacion Aiken de la Comunitat Valenciana
Valencia
Oftalvist
Valencia
United Kingdom
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
Time Frame
Start Date: 2024-05-30
Completion Date: 2027-09
Participants
Target number of participants: 313
Treatments
Experimental: Elamipretide
Subjects will receive once daily subcutaneous doses of 40mg elamipretide for 96 weeks
Placebo_comparator: Placebo
Subjects will receive once daily subcutaneous doses of placebo for 96 weeks
Sponsors
Leads: Stealth BioTherapeutics Inc.

This content was sourced from clinicaltrials.gov

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