1. ILUVIEN® [package insert]. Alpharetta, GA: Alimera Sciences, Inc. 2. Parrish RK, Campochiaro PA, Pearson PA, Green K, Traverso CE, FAME Study Group. Characterization of intraocular pressure increases and management strategies following treatment with fluocinolone acetonide intravitreal implants in the FAME trials. Ophthalmic Surg Lasers Imaging Retina. 2016;47:426-435.
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.
Study arms:
956 subjects randomized 2:2:1
2 μg/qd FAc intravitreal insert
5 μg/qd FAc intravitreal insert
Sham injection
Primary endpoint:
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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