Phase 1 Clinical Trial of Elamipretide in Dry Age-Related Macular Degeneration and Noncentral Geographic Atrophy: ReCLAIM NCGA Study.

ABSTRACT:

Purpose

Assess the safety, tolerability, and feasibility of subcutaneous administration of the mitochondrial-targeted drug elamipretide in patients with dry age-related macular degeneration (AMD) and noncentral geographic atrophy (NCGA) and to perform exploratory analyses of change in visual function.

Design

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

Participants

Adults ≥ 55 years of age with dry AMD and NCGA.

Methods

Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout. Ocular assessments included normal-luminance best-corrected visual acuity (BCVA), low-luminance BCVA (LLBCVA), normal-luminance binocular reading acuity (NLBRA), low-luminance binocular reading acui

SUBMITTER: Mettu PS 

PROVIDER: S-EPMC9560640 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature