| Subconjunctival sirolimus for the treatment of chronic active anterior uveitis: results of a pilot trial. | |
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MedLine Citation:
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PMID: 22465364 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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H Nida Sen; Theresa A Larson; Annal D Meleth; Wendy M Smith; Robert B Nussenblatt |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, N.I.H., Intramural Date: 2012-04-01 |
Journal Detail:
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Title: American journal of ophthalmology Volume: 153 ISSN: 1879-1891 ISO Abbreviation: Am. J. Ophthalmol. Publication Date: 2012 Jun |
Date Detail:
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Created Date: 2012-05-21 Completed Date: 2012-08-07 Revised Date: 2013-06-06 |
Medline Journal Info:
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Nlm Unique ID: 0370500 Medline TA: Am J Ophthalmol Country: United States |
Other Details:
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Languages: eng Pagination: 1038-42 Citation Subset: AIM; IM |
Copyright Information:
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Published by Elsevier Inc. |
Affiliation:
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National Eye Institute, National Institutes of Health, Bethesda, MD 20892, USA. senh@nei.nih.gov |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00876434 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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ZIA EY000500-01/EY/NEI NIH HHS; ZIA EY000500-02/EY/NEI NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Immunosuppressive Agents; 53123-88-9/Sirolimus |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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