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G.J. Jaffe, D. Martin, D. Callanan, B. Levy, Fluocinolone Acetonide Implant Uveitis Study Group; Fluocinolone Acetonide Intravitreal Implant to Treat Posterior Uveitis: 2–year Results of a Multi–Center Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2386.
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Purpose: A multi–center, randomized, dose–masked clinical trial was conducted to determine the safety and efficacy of a sustained release fluocinolone acetonide intravitreal implant in patients with posterior uveitis. Methods: Two hundred and seventy eight patients were randomized to receive either a 0.59mg or 2.1mg implant. Outcome measures included recurrence rate, visual acuity, adjunctive therapy use and adverse events. Results: At one year post–implantation, the aggregate recurrence rate for the implanted eyes was 4.3% versus 56.3% for the non–implanted fellow eyes (p<0.0001). Baseline visual acuity improved by three lines or better in 26.2% of the device–implanted eyes compared to 6.2% in the non–implanted fellow eyes. Adjunctive therapy use also significantly decreased post implantation. Systemic corticosteroid and/or immunosuppressive therapy was used by 58.8% of patients at baseline versus 11.9% of patients at 52 weeks (p<0.0001). In the 12 months prior to implantation, 70.9% of study eyes were given sub–Tenon injections versus 4.3% post implantation (p<0.0001). Similarly, topical steroid use was also reduced; 29.1% of study eyes at baseline versus 4.7% at 52 weeks (p<0.0001). The most common serious adverse events included cataract extraction (25.9%) and filtering procedures (11.9%). Conclusions: At one year, the fluocinolone acetonide implant controlled inflammation and resulted in a decrease in adjunctive therapy use in the studied patient population. Intraocular pressure and lens clarity must be closely monitored in this patient population. The two year extended follow–up results will be presented.
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