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T. A. Ciulla, FAME Studies Group; Fluocinolone Acetonide Intravitreal Insert (Iluvien®) Phase 3 Studies: Demographics. Invest. Ophthalmol. Vis. Sci. 2010;51(13):5844.
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The FAME studies are phase 3 comparisons of the efficacy and safety of 2 doses of Iluvien® (fluocinolone acetonide intravitreal insert, Alimera Sciences Inc.) to sham injections for the treatment of diabetic macular edema (DME). The design of the trials and demographics of the population will be described.
The studies (A and B) included subjects with DME with central retinal thickness >250µ by TD-OCT who had received at least 1 macular laser treatment. Baseline best corrected visual acuity was required to be >18 and <69 ETDRS letters. Subjects from 103 sites in North American, Europe and India were randomized in a 2:2:1 (0.2 µg/day, 0.5 µg/day, sham) ratio. Subjects could receive an additional study treatment any time after the month 12 visit, if progression of edema had occurred.
Enrollment for the two trials was completed with a total of 956 subjects. Baseline data for the aggregate indicates that the population studied is typical of DME subjects: Mean age, 62.5 years; 59.3% male; 92.1% Type 2 diabetes mellitus with a mean HbA1c of 7.8%. There were 69.7% Caucasian and 22.2% Asian subjects and 15.4% had received intravitreal steroid injections before the study. The specifics for Studies A and B will be discussed.
The baseline demographics of the FAME trials suggest that this program will provide useful information not only on the outcome of subjects with DME who were treated with intravitreal FA, but on the progression of DME in subjects who did not receive FA. The Month 24 readout will be available in December 2009.
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