For Physicians
Dry AMD Clinical Trials Study Design for ReNEW
Do you have a patient with dry AMD who may be interested in the ReNEW clinical trial?
ReNEW is a Phase 3, randomized, double-masked, placebo-controlled study that will evaluate the efficacy, safety, and pharmacokinetics of subcutaneous injections of elamipretide in subjects who have dry AMD.
The study drug, elamipretide, is a subcutaneous injection taken once daily that is being compared to placebo. Eligible participants will be treated in a 2:1 randomization with either elamipretide or placebo for 96 weeks. Eventually, all participants enrolled in the ReNEW dry AMD clinical trials will have the opportunity to receive the study drug in the ReTAIN 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.
The primary objective of the ReNEW dry AMD clinical trial 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 (study eye) with dry AMD with photoreceptor loss, as determined at the Screening Visit by the presence of extrafoveal GA, as determined by the Reading Center primarily by 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.
- 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.
Additional eligibility requirements, including exclusion criteria, may apply, which can be found at clintrials.gov.