Intravitreal sirolimus for the treatment of geographic atrophy: results of a phase I/II clinical trial.

ABSTRACT:

Purpose

To investigate the safety and effects of intravitreal sirolimus for the potential treatment of geographic atrophy (GA).

Methods

The study was a single-center, open-label, phase I/II trial enrolling six participants with bilateral GA treated with intravitreal sirolimus in only one randomly assigned eye, with the fellow eye as control. The primary efficacy outcome measure was the change in total GA area from baseline on color fundus photography (CFP); secondary outcomes included changes in GA area on fundus autofluorescence (FAF), visual acuity, central retinal thickness (CRT), and macular sensitivity from baseline.

Results

Although no systemic adverse events were attributed to treatment, two of six participants had ocular adverse events that were possibly assoc

SUBMITTER: Petrou PA 

PROVIDER: S-EPMC4294293 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature