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P. Pearson, B. Levy, Fluconolone Acetonide Implant Study Group; Fluocinolone Acetonide Intravitreal Implant to Treat Diabetic Macular Edema: 2–year Results of a Multi–Center Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2005;46(13):4673.
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Purpose: A multi–center, randomized, controlled clinical trial was conducted to determine the safety and efficacy of a sustained release fluocinolone acetonide intravitreal implant in patients with diabetic macular edema. Methods: One hundred and ninety–seven patients were randomized to receive either a 0.59mg fluocinolone implant or standard of care (repeat laser or observation) in a 2:1 ratio. Outcome measures included resolution of at the center of the macula, diabetic retinopathy scores, visual acuity and safety. Results: At 12 months post–implantation, 57.0% eyes receiving the implant versus 20.3% of eyes receiving standard of care had no evidence of edema at the center of the macula (p<0.001). Moreover, 55.6% of eyes receiving the implant demonstrated a 2–step improvement in retinal thickness at the center of the macula compared to 17.2% of eyes receiving standard of care (p<0.001). A greater proportion of device–implant eyes (16.8%) demonstrated a greater than one step decrease in the diabetic retinopathy severity scores compared to 5.0% of eyes receiving standard of care (p=0.002). At 12 months, there was no difference in visual acuity between the eyes receiving the implant and standard of care (p=0.16). The most common adverse events in the device–implanted eyes included serious cataract progression (43.1%) and a serious intraocular pressure rise (8.6%); five eyes (3.9%) required filtering procedures. Conclusions: At 12 months, the fluocinolone acetonide implant resulted in resolution of edema at the center of the macula in a significant proportion of the eyes studied. 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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