ReNEW
Research type
Research Study
Full title
ReNEW: A Phase 3, Randomized, 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)
IRAS ID
1010005
Contact name
Hess Suh
Contact email
Sponsor organisation
Stealth BioTherapeutics Inc.
Clinicaltrials.gov Identifier
Research summary
Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in people aged 55 or older in the developed world. This study is looking at patients who have dry AMD.
Research suggests that dry AMD is caused by damage and deterioration of the mitochondria, which are constituents of the body’s cells that produce energy. Damage to the mitochondria may contribute to the loss of vision seen in the disease. There is currently no treatment for dry AMD.
The study drug, Elamipretide, is a mitochondrial protective agent that has been shown to improve cell viability and organ function across a spectrum of diseases, including ophthalmic disease and, in models of dry AMD, has been shown to improve retinal mitochondrial function, prevent disease progression, and improve visual function.
Patients will receive daily subcutaneous injections of elamipretide, or placebo (randomization 2:1) for up to 96 weeks. Patients will either inject themselves or a caregiver will administer the injections.
Overall, the study will last up to 104 weeks for each patient, with 12 study visits during this period. Patients may also enter an open-label phase of the study after the 96-week treatment period.
At each of the 12 study visits, participants will undergo a number of eye examinations, imaging of the retina, blood tests, physical examinations, and review of medical history, concomitant medication and adverse events.
About 360 patients, at least 55 years of age and who have been diagnosed with dry AMD, are expected to take part in this study at approximately 65 clinical trial sites around the world. Around 10 of these will be in the UK, conducted at specialist eye hospitals or ophthalmology clinics in general hospitals.
There is no guarantee of benefits for participants but elamipretide may help to prevent progression of dry AMD.
The study sponsor is Stealth BioTherapeutics, Massachusetts, USA.REC name
London - Riverside Research Ethics Committee
REC reference
24/LO/0418
Date of REC Opinion
19 Aug 2024
REC opinion
Further Information Favourable Opinion