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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Age Related Macular Degeneration (ARMD)

In brief

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.

Key facts

Study ID

NCT06373731

Run by

Stealth BioTherapeutics Inc.

People needed

313

Starts

2024-05-30

Expected to finish

2027-09-01

Last updated by the study team

2026-05-20

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Barnet Dulaney Perkins Eye Center — Sun City, Arizona, United States
• Retina Associates of Southern California — Huntington Beach, California, United States
• Retina Consultants of San Diego — Poway, California, United States
• Retinal Consultants Medical Group — Sacramento, California, United States
• Orange County Retinal Medical Group — Santa Ana, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Retina Consultants of Southern Colorado — Colorado Springs, Colorado, United States
• Connecticut Eye Consultants, P.C. — Danbury, Connecticut, United States
• Vitreo Retinal Associates — Gainesville, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
• University Retina and Macula Associates — Oak Forest, Illinois, United States
• Associated Vitreoretinal and Uveitis Consultants — Carmel, Indiana, United States
• Mid Atlantic Retina Specialist — Hagerstown, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Kellogg Eye Center — Ann Arbor, Michigan, United States
• Retina Consultants of Minnesota — Minneapolis, Minnesota, United States
• Mid Atlantic Retina — Cherry Hill, New Jersey, United States
• NJ Retina — Teaneck, New Jersey, United States
• Retina Vitreous Center — Edmond, Oklahoma, United States
• Retina Northwest, PC — Portland, Oregon, United States
• Retina Research Institute of Texas — Abilene, Texas, United States
• Austin Clinical Research, LLC — Austin, Texas, United States
• Retina Consultants of Texas — Bellaire, Texas, United States
• Associated Retina Consultants — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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