Purchase this article with an account.
G.J. Jaffe, D.F. Martin, D. Callanan, B. Levy, T. Comstock, Fluocinolone Acetonide Implant Uveitis Study Group; Fluocinolone Acetonide Intravitreal Implant to Treat Posterior Segment Uveitis: 3–Year Results of a Multi–Center Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2006;47(13):1523.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
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 segment uveitis.
Two hundred and seventy eight patients diagnosed with chronic non–infectious recurrent posterior segment uveitis 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.
Aggregate recurrence rate for the implanted eyes increased from 11% at two years to 33% at three years post–implantation. Three year recurrence rate was significantly higher in the non–implanted fellow eyes (57%, p<0.001). Baseline visual acuity improved by three lines or better in 22% of the implanted eyes compared to 6% in the non–implanted fellow eyes at 3 years (p<0.001). The most common serious adverse events included cataract extraction (92%) and filtering procedures (43%), five eyes (2%) were explanted for control of IOP.
Control of inflammation with the fluocinolone acetonide implant at 3 years, although still significantly better than in non–implanted eyes, was less effective than the control of inflammation reported at 2 years. This finding suggests that some eyes may require replacement of the implant between the 24M and 36M time points. Three or more line improvements in visual acuity continue to be seen in a significantly greater percentage of implanted than non–implanted eyes at 36M. Intraocular pressure and lens clarity must continue to be closely monitored in this patient population.
This PDF is available to Subscribers Only