Phase 1 Clinical Trial of Elamipretide in Intermediate Age-Related Macular Degeneration and High-Risk Drusen: ReCLAIM High-Risk Drusen Study.

ABSTRACT:

Purpose

To assess safety, tolerability, and feasibility of subcutaneous administration of the mitochondrial-targeted drug elamipretide in patients with intermediate age-related macular degeneration (AMD) and high-risk drusen (HRD) and to perform exploratory analyses of change in visual function.

Design

Phase 1, single-center, open-label, 24-week clinical trial with preplanned HRD cohort.

Participants

Adult patients ≥55 years of age with intermediate AMD and HRD.

Methods

Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study. Ocular assessments included normal-luminance best-corrected visual acuity (BCVA), low-luminance best-corrected visual acuity (LLVA), normal-luminance binocular reading acuity

SUBMITTER: Allingham MJ 

PROVIDER: S-EPMC9560633 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature