Document Detail


Subconjunctival sirolimus for the treatment of chronic active anterior uveitis: results of a pilot trial.
MedLine Citation:
PMID:  22465364     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
H Nida Sen; Theresa A Larson; Annal D Meleth; Wendy M Smith; Robert B Nussenblatt
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, N.I.H., Intramural     Date:  2012-04-01
Journal Detail:
Title:  American journal of ophthalmology     Volume:  153     ISSN:  1879-1891     ISO Abbreviation:  Am. J. Ophthalmol.     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-05-21     Completed Date:  2012-08-07     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  0370500     Medline TA:  Am J Ophthalmol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1038-42     Citation Subset:  AIM; IM    
Copyright Information:
Published by Elsevier Inc.
Affiliation:
National Eye Institute, National Institutes of Health, Bethesda, MD 20892, USA. senh@nei.nih.gov
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00876434
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MeSH Terms
Descriptor/Qualifier:
Adult
Chronic Disease
Conjunctiva / drug effects
Female
Humans
Immunosuppressive Agents / administration & dosage*,  adverse effects
Injections, Intraocular
Male
Middle Aged
Pilot Projects
Prospective Studies
Sirolimus / administration & dosage*,  adverse effects
Treatment Outcome
Uveitis, Anterior / drug therapy*,  physiopathology
Visual Acuity / physiology
Grant Support
ID/Acronym/Agency:
ZIA EY000500-01/EY/NEI NIH HHS; ZIA EY000500-02/EY/NEI NIH HHS
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 53123-88-9/Sirolimus
Comments/Corrections

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