This Article  • Full text  • PDF  • eFigures  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (13)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Cataracts/ Lens  • Macular Disorders  • Uveitis  • Ophthalmological Procedures, Other  • Randomized Controlled Trial  • Articles for Residents  • Drug Therapy  • Adverse Effects  • Alert me on articles by topic  Social Bookmarking   What's this?

Three-Year Clinical Trial Results

David G. Callanan, MD; Glenn J. Jaffe, MD; Daniel F. Martin, MD; P. Andrew Pearson, MD; Timothy L. Comstock, OD

Arch Ophthalmol. 2008;126(9):1191-1201.

Objectives  To evaluate the safety and efficacy of 0.59-mg and 2.1-mg fluocinolone acetonide (FA) intravitreous implants in noninfectious posterior uveitis.

Design  A 3-year, multicenter, randomized, historically controlled trial of the 0.59-mg FA intravitreous implant in 110 patients and the 2.1-mg FA intravitreous implant in 168 patients.

Main Outcome Measures  Recurrence rate, vision, and complications.

Results  Uveitis recurrence was reduced in implanted eyes from 62% (during the 1-year preimplantation period) to 4%, 10%, and 20% during the 1-, 2-, and 3-year postimplantation periods, respectively, for the 0.59-mg dose group (P < .01) and from 58% to 7%, 17%, and 41%, respectively, for the 2.1-mg dose group (P < .01). More implanted eyes than nonimplanted eyes had improved visual acuity (P < .01). Implanted eyes had higher incidences of intraocular pressure elevation ( 10 mm Hg) than nonimplanted eyes (P < .01), and glaucoma surgery was required in 40% of implanted eyes vs 2% of nonimplanted eyes (P < .01). Cataracts were extracted in 93% of phakic implanted eyes vs 20% of phakic nonimplanted eyes (P < .01).

Conclusions  The FA implant significantly reduced uveitis recurrence and improved or stabilized visual acuity in subjects with noninfectious posterior uveitis. Most subjects required cataract extraction, and a significant proportion required intraocular pressure–lowering surgery.

Application to Clinical Practice  The FA implant provides an alternative therapy for prolonged control of inflammation in noninfectious posterior uveitis.

Trial Registration  clinicaltrials.gov Identifier: NCT00407082

Author Affiliations: Texas Retina Associates, Arlington, and University of Texas Southwestern Medical School, Dallas (Dr Callanan); Duke University Eye Center, Durham, North Carolina (Dr Jaffe); Emory Eye Center, Emory University School of Medicine, Atlanta, Georgia (Dr Martin); Department of Ophthalmology and Visual Sciences, University of Kentucky, Lexington (Dr Pearson); and Bausch & Lomb, Rochester, New York (Dr Comstock).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Management of Fluocinolone Implant Dissociation During Implant Exchange
Yeh et al.
Arch Ophthalmol 2009;127:1218-1221.
ABSTRACT | FULL TEXT  

Three-Year Follow-up of a Randomized Trial Comparing Focal/Grid Photocoagulation and Intravitreal Triamcinolone for Diabetic Macular Edema
Diabetic Retinopathy Clinical Research Network (DR
Arch Ophthalmol 2009;127:245-251.
ABSTRACT | FULL TEXT  

Uveitis Treated With Fluocinolone Acetonide Implants--Reply
Goldstein et al.
Arch Ophthalmol 2009;127:116-116.
FULL TEXT  

Fluocinolone Acetonide for the Treatment of Uveitis: Weighing the Balance Between Local and Systemic Immunosuppression
Yeh and Nussenblatt
Arch Ophthalmol 2008;126:1287-1289.
FULL TEXT