Treatment of Posterior Uveitis With a Fluocinolone Acetonide Implant
Three-Year Clinical Trial Results
- Callanan, David G. MD
- Jaffe, Glenn J. MD
- Martin, Daniel F. MD
- Pearson, P. Andrew MD
- Comstock, Timothy L. OD
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