Evaluation of Oral Minocycline in Treating Geographic Atrophy Associated with Age-Related Macular Degeneration

National Eye Institute

Investigators

Linked publications, trials & patents

Abstract

This was a multi-center, prospective, single-arm, Phase II study to evaluate minocycline as a potential treatment to decrease the rate of worsening of geographic atrophy (GA) associated with AMD. Participants underwent a nine month run-in phase prior to receiving investigational product (IP). Following the run-in phase, beginning at Month 9, participants received an oral dose of 100 mg of minocycline twice daily for 36 months. The primary outcome was the rate of change in area of GA based on grading by an external Reading Center of fundus autofluorescence (FAF) images in the assigned study eye. The primary outcome compared the rates of GA area expansion as determined on FAF images before and following the initiation of IP until 24 months of treatment. Secondary outcomes included comparing differences in rates of change in best-corrected visual acuity (BCVA), low-luminance VA, area of GA based on fundus photography, and macular sensitivity as measured using microperimetry between the run-in and treatment phases. Safety outcomes included the number and severity of adverse events (AEs).