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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).

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Fluocinolone Acetonide for the Treatment of Uveitis: Weighing the Balance Between Local and Systemic Immunosuppression
Steven Yeh and Robert B. Nussenblatt
Arch Ophthalmol. 2008;126(9):1287-1289.
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