About the Studies
ReNEW and ReGAIN Are Evaluating New Treatments for Dry AMD
The ReNEW and ReGAIN studies are two global research studies evaluating a new treatment for dry AMD. The studies evaluate the efficacy of once-daily subcutaneous (SC) injections of the investigational therapy, elamipretide, in subjects who have dry age-related macular degeneration (dry AMD). The investigational medicinal product, elamipretide, will be compared to placebo.
The duration of research studies for new treatments for dry AMD is approximately 80 weeks and consists of a screening period (up to 4 weeks), a masked treatment period (72 weeks)), and a safety follow-up period (4 weeks) with the option to enroll in the open-label extension period (for up to 130 weeks).
About the Investigational Medicine
The research studies will evaluate a treatment for dry AMD using the investigational therapy, elamipretide. Elamipretide is an investigational peptide compound that readily penetrates cell membranes and targets the inner mitochondrial membrane, where it binds reversibly to cardiolipin. Elamipretide is a mitochondrial protective agent that has been shown in preclinical studies to normalize mitochondrial structure and function and improve cell viability and organ function across a spectrum of disease models, including models of cardiovascular, renal, metabolic, skeletal muscle, neurodegenerative, and genetic mitochondrial disease. Currently, elamipretide is administered via subcutaneous injection.
The study drug was previously assessed in a phase 2, randomized, double-masked, placebo-controlled clinical study to evaluate the safety, efficacy, and pharmacokinetics of subcutaneous injections of elamipretide in subjects with dry AMD with geographic atrophy.
Dry AMD Treatment Study Participation
Participation in the study consists of the following periods:
Screening Period
This period may last up to four weeks. The study team will perform several assessments and procedures to determine whether interested individuals are eligible to participate.
Masked Treatment Period
This period lasts approximately 96 weeks. After randomization, participants will receive either study treatment or placebo treatment and attend visits at the study site for routine assessments and procedures. “Masked” means that neither you nor the study doctor will know whether you are receiving the investigational medication or the placebo.
Follow-Up Period
For subjects not enrolling in the ReTAIN open-label extension, the 4-week Safety Follow-Up Period will begin after the masked treatment period is completed. Subjects will return to the clinical site on Week 100 for a final safety assessment.
During the Treatment Period, study participants will return to the clinical site at Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, and Week 72 for assessments on the new treatment for dry AMD. On non-visit days, subjects (or trained caregivers) will administer the investigational medicinal product or placebo daily during the Treatment Period and record it in a diary provided by the study sponsor. During the Treatment Period, subjects will continue to follow all trial requirements, including documenting the location and time of the daily injection in the diary.