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Sustained release fluocinolone acetonide has the potential to become an effective long-term treatment for DME.
The phase III FAME study consisted of two randomized, double-masked, parallel group, multicenter, dose-finding trials (Trial A and Trial B) that were designed to assess the safety and efficacy of 0.2 µg/d and 0.5 µg/d FA intravitreal inserts versus sham injection in patients with DME, according to Dr. Regillo, director of Retina Research at Wills Eye Institute and professor of ophthalmology at Thomas Jefferson University, Philadelphia.
Key inclusion criteria into the study included the following:
The secondary efficacy variables included mean change from baseline in BCVA letter score; mean change from baseline in the excess center point thickness; and proportion of subjects with ≥ 3 step worsening of diabetic retinopathy.
"The average duration of diabetes in these patients was 16 to 17 years," Dr. Regillo said. "The average duration of DME was also long-standing, at about 3.5 to 4 years, and the majority of eyes (62% to 67%) were phakic."