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P. Pearson, B. Levy, T. Comstock, Fluocinolone Acetonide Implant Study Group; Fluocinolone Acetonide Intravitreal Implant to Treat Diabetic Macular Edema: 3–Year Results of a Multi–Center Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5442.
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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.
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 edema at the center of the macula, diabetic retinopathy scores, visual acuity and safety.
Implanted eyes exhibited less macular edema than SOC eyes (p<0.001) at 36 months post–implantation. There was no evidence of edema in 58% of eyes receiving the implant versus 30% of eyes receiving SOC, 45% of implanted eyes demonstrated a greater than 2–step improvement in retinal thickness at the center of the macula compared to 24% of SOC eyes. Improvements in diabetic retinopathy scores were greater in implanted versus SOC eyes (p<0.001), 13% of implanted eyes and 4% of SOC eyes demonstrated a >1 step improvement. Visual acuity improvements of 3 or more lines were seen more often in test eyes (28% vs 15%, p<0.05) while differences in VA loss of 3 or more lines (19% test, 16% control) were statistically insignificant. The most common serious adverse events in the device–implanted eyes included cataract requiring extraction in 95% of phakic implanted eyes and intraocular pressure rise (35%); thirty–six eyes (28%) required a filtering procedure and 6 eyes (5%) were explanted to manage IOP.
At 36 months, the fluocinolone acetonide implant resulted in resolution of edema at the center of the macula and a 3 or more line improvement in visual acuity in a significant proportion of the eyes studied. Intraocular pressure and lens clarity must be closely monitored in this patient population.
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