For Physicians
Dry AMD Clinical Trials Study Design for ReNEW and ReGAIN
Do you have a patient with dry AMD who may be interested in the ReNEW and ReGAIN clinical trials?
ReNEW and ReGAIN are Phase 3, randomized, double-masked, placebo-controlled studies to evaluate the efficacy, safety, and pharmacokinetics of subcutaneous injections of elamipretide in subjects who have dry AMD.
The investigational medicinal product, elamipretide, is a subcutaneous injection taken once daily that is being compared with a placebo. Eventually, all participants enrolled in the ReNEW and ReGAIN Dry AMD clinical trials will have the opportunity to receive the investigational medication in an open-label extension.
The duration of participation 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 your patient in the open-label extension period (for up to 130 weeks).
The primary objective of the ReNEW and ReGAIN Dry AMD clinical trials is to evaluate the efficacy of once-daily subcutaneous injections of elamipretide in subjects who have dry age-related macular degeneration.
Study Eligibility for Dry AMD Clinical Trials
Key Inclusion Criteria:
- Adults ≥ 55 years of age with at least 1 eye with dry AMD with photoreceptor loss, as determined by the presence of extrafoveal GA.
- 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 ≥ 0.05 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 at the Screening Visit and Baseline Visit.
- Low luminescence BCVA by ETDRS score of ≥ 10 letters in the study eye at the Screening Visit and Baseline Visit.
- LLD (defined as the difference between BCVA and LL BCVA) of > 5 letters in the study eye at Screening and Baseline Visits.
- 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 and/or complement inhibitor therapies in the fellow eye is allowable.
- 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.
Additional eligibility requirements, including exclusion criteria, may apply, which can be found at clintrials.gov.
Trial Site Finder
Find the participating ReNEW and ReGAIN research sites(s) nearest you.