Subconjunctival sirolimus for the treatment of chronic active anterior uveitis: results of a pilot trial

Abstract

Purpose: To evaluate the safety and possible efficacy of subconjunctival sirolimus for the treatment of chronic active anterior uveitis.

Design: Prospective, nonrandomized, open-label clinical trial.

Methods: This single-center pilot trial enrolled 5 patients with chronic active anterior uveitis. The study drug was administered as a single subconjunctival injection of 30 μL (1320 μg) sirolimus in the study eye at the baseline visit. Study visits were performed at baseline, at 2 weeks, at 4 weeks, and monthly until 4 months, and included a complete ophthalmic examination, review of systems, adverse event assessment at each visit, physical examination, and ancillary ophthalmic testing at some visits. The primary outcome measure was a 2-step reduction in the anterior chamber inflammation within 4 weeks of injection of the study drug.

Results: There were 3 female and 2 male patients; 4 patients had idiopathic anterior uveitis and 1 had psoriatic arthritis-associated anterior uveitis. Three of the 5 patients met the primary outcome criteria by showing at least a 2-step decrease in inflammation within 4 weeks; 2 patients showed a 1-step decrease in inflammation within the same time frame. No recurrence was encountered during a 4-month follow-up. There were no serious adverse events.

Conclusions: Subconjunctival sirolimus appears to be well tolerated in this pilot trial and shows promise as a treatment for active inflammation in patients with chronic anterior uveitis. Larger studies are needed to assess its usefulness in uveitis.

Trial registration: ClinicalTrials.gov NCT00876434.

Published by Elsevier Inc.

Figures

Figure

Anterior chamber (AC) inflammation in the study eyes. Change in inflammation over 16 weeks following subconjunctival sirolimus injection in the study eyes of 5 patients with chronic active anterior uveitis is shown.