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Peter A Campochiaro, FAME; Long-term visual outcomes based on baseline vision in patients with chronic diabetic macular edema (DME) treated with fluocinolone acetonide (FAc). Invest. Ophthalmol. Vis. Sci. 2014;55(13):1783.
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ILUVIEN® (intraocular, nonbioerodible, 0.2 μg/d FAc implant) is approved in 7 European countries for the treatment of chronic DME considered insufficiently responsive to available therapies. Here we examine response among patients with chronic DME in the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) study based on baseline vision.
The FAME study (2 randomized, multicenter, 36-month, phase 3 trials under a single protocol) assessed efficacy and safety of 0.2 μg/d FAc and 0.5 μg/d FAc vs sham injection (control) in patients with DME. These trial results indicated greatest benefit was seen in patients with chronic DME (≥ 3 years at baseline). Patients with chronic DME were analyzed for clinical benefit based on baseline best corrected visual acuity (BCVA).
At baseline, ≈ 43% of patients with chronic DME had BCVA ≤ 20/100 (48/112 [42.9%] control and 90/209 [43.1%] 0.2 μg/d FAc-treated patients); ≈ 60% had BCVA ≤ 20/80 (63/112 [56.3%] and 124/209 [59.3%], respectively) and ≈ 80% had BCVA ≤ 20/60 (90/112 [80.4%] and 161/209 [77.0%], respectively). Among all patients with chronic DME, the proportion with ≥ 15-letter improvement at month 36 was 13.4% for control and 34.0% for 0.2 μg/d FAc-treated patients, a treatment difference of 20.6%. Among patients with chronic DME with baseline BCVA ≤ 20/60, 14.4% of control and 38.5% of 0.2 μg/d FAc-treated patients experienced ≥ 15-letter improvement (treatment difference, 24.1%). For those with ≤ 20/80 baseline vision, these values were 12.7% vs 42.7% (treatment difference, 30%), and those with ≤ 20/100 had the greatest benefit, 12.5% vs 46.7% (treatment difference, 34.2%). At 36 months, mean change in BCVA among those with ≤ 20/80 vision was +2.1 vs +10.7 letters for control and 0.2 μg/d FAc, respectively (P = .002). Among those with ≤ 20/100 vision, mean change was +1.5 vs +12.2 letters, respectively (P < .001).
Robust 36-month efficacy was noted in patients with chronic DME treated with 0.2 μg/d FAc, with treatment difference from sham being even more pronounced in patients with lower baseline visual acuity. In the FAME trial, long-term sustained-release corticosteroid therapy provided the greatest benefit in patients with worst baseline disease.
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