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Clinical Trial
. 2012 Jun;153(6):1038-42.
doi: 10.1016/j.ajo.2011.12.018. Epub 2012 Apr 1.

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

H Nida Sen  1 , Theresa A Larson, Annal D Meleth, Wendy M Smith, Robert B Nussenblatt
Affiliations
Clinical Trial

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

H Nida Sen et al. Am J Ophthalmol. 2012 Jun.

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.

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Figures

Figure
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.
See this image and copyright information in PMC

References

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