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Anjali Parekh, Sunil Srivastava, Thomas Albini, Quan Dong Nguyen, Debra Goldstein; Risk Factors Associated with Intraocular Pressure Rise in Patients with Uveitis Treated with the Fluocinolone Acetonide Implant. Invest. Ophthalmol. Vis. Sci. 2013;54(15):5196.
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The fluocinolone acetonide (FA) intravitreal implant (Retisert; Bausch & Lomb, Inc., Rochester, New York, USA) is an FDA approved therapy for the treatment of chronic non-infectious intermediate, posterior, and pan-uveitis. The efficacy of this implant has been demonstrated by three 3 year multicenter, prospective, randomized clinical trials. Elevated intraocular pressure is a well-known adverse event secondary to the use of the FA intravitreal implant. In a study evaluating the incidence and management of elevated IOP in patients with uveitis treated with the FA implant, topical IOP lowering medications were administered in 74.8% of implanted eyes, and IOP lowering surgeries were performed in 36.6% of implanted eyes by 3 years. The purpose of this investigation is to report associated patient risk factors that may predispose to elevated intraocular pressure following treatment with the intravitreal FA implant
Pooled data from the previously published 3 multicenter, double-masked, randomized, controlled phase 2b/3 clinical trials evaluating the safety and efficacy of the 0.59 mg or 2.1mg FA intravitreal implant were analyzed to characterize risk factors associated with elevated IOP. Risk factors studied included age, gender, race, and location of uveitis. All eyes implanted with either the 0.59mg FA implant or the 2.1mg FA implant were included in the analysis. Frequencies of patients with glaucoma surgery were compared using Pearson chi-square or Fisher exact tests for categorical factors and t-tests for continuous measures. Analyses were performed in SAS software and used a 0.05 significance level.
290 eyes received an FA implant. Male gender was associated with an increased risk of requiring glaucoma surgery (p= 0.037), as was younger age (p= 0.006). No statistically significant difference was found between Caucasians and non-Caucasian patients. (p=0.38) Patients with posterior uveitis were more likely than those with anterior, intermediate, or panuveitis to require surgery (p=0.006).
The risk of requiring glaucoma surgery in this series was highest in males, younger patients and those with posterior uveitis. This information can be used to counsel patients considering treatment with the FA implant.
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