A new dry AMD study. The rate of change in the macular area of photoreceptor loss is the primary efficacy endpoint of ReNEW and ReTAIN trials.
Stealth BioTherapeutics has enrolled the first subject in the Phase III ReNEW clinical trial as part of a clinical program to assess elamipretide for treating patients with dry age-related macular degeneration (AMD).
The randomized, double-masked, placebo-controlled ReNEW trial will evaluate the efficacy, safety, and pharmacokinetics of once-a-day doses of elamipretide given as subcutaneous injections.
It will involve 360 patients who will receive either a 40mg dose of elamipretide or a placebo for 96 weeks.
Participants in the ReNEW trial have the opportunity to join a Phase III open-label extension trial, ReTAIN, upon completion.
The ReNEW trial is part of a larger program that includes the ReGAIN trial, which similarly investigates the daily subcutaneous administration of elamipretide in subjects with dry AMD.
Source: Clinical Trail Arena