USER was a retrospective study of 160 eyes in 130 patients receiving ILUVIEN.
Determine correlations of VA and retinal thickness to DME treatments prior to and post-ILUVIEN
Compare the number of DME treatments used prior to and post-ILUVIEN
Compare the IOP signals associated with ILUVIEN to IOP signals reported in the FAME study
Data on file. Alimera Sciences, Inc.
Study Design: FAME
FAME A and B were randomized, double-masked, sham injection-controlled, parallel-group, multicenter studies conducted under a single protocol over 36 months.
956 subjects randomized 2:2:1
2 μg/qd FAc intravitreal insert
5 μg/qd FAc intravitreal insert
Proportion of subjects with improvement in BCVA ≥ 15 letters at 24 months
Inclusion criteria: Foveal thickness ≥ 250 μm despite ≥ 1 prior focal/grid macular laser photocoagulation treatment and BCVA in ETDRS letter score between 19 and 68 (20/50–20/400).
Exclusion criteria: Glaucoma, ocular hypertension, IOP > 21 mm Hg, or using IOP-lowering drops.
Campochiaro PA, Brown DM, Pearson A, et al. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119:2125-2132.
Campochiaro PA, Brown DM, Pearson A, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology. 2011;118:626-635.
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