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Monica Santos, António Campos, Arminda Neves, Pedro Alfaiate, Joana Pereira, João Paulo Castro e Sousa; Safety and efficacy of fluocinolone acetonide intravitreal implant (Iluvien®) in patients with chronic diabetic macular edema in a real-life setting. Invest. Ophthalmol. Vis. Sci. 2017;58(8):5032.
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The FAME study demonstrated the efficacy and safety of the fluocinolone acetonide (FAc) implant, ILUVIEN®, in eyes of patients with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. The purpose of this study was to evaluate the efficacy and safety of FAc 190 μg implant in the treatment of DME in a real world basis.
This non-interventional, retrospective, case series evaluated 20 eyes of 16 patients with mean DME duration of 6 years, that did not respond sufficiently to previous treatments (laser, anti-VEGF or corticosteroids) and received one single intravitreal FAc implant (190 μg). Main outcomes were measured at baseline, 1, 3 and 6 months and included: best-corrected visual acuity (BCVA), central macular thickness (CMT), macular volume (MV) and intraocular pressure (IOP).
Twenty eyes of sixteen patients were included, 11 males and 5 females, with a mean age of 67,45±10,73 years. Seventeen eyes were pseudophakic and 3 were phakic. All eyes treated received prior treatments: laser (19 eyes), intravitreal agents including bevacizumab (2 eyes), ranibizumab (16 eyes), aflibercept (3 eyes), triamcinolone (11 eyes) and dexamethasone implant (11 eyes). Seven eyes underwent previous vitrectomy. At baseline mean (±standard deviation) BCVA was 50,25±12,23 ETDRS letters, CMT 516.60±176.96 μm, MV 11.23±2.69 mm3 and IOP 14.47±3.57 mmHg. The mean change of BCVA and IOP from baseline to month 6 did not show a significant difference. At month 3, there was a statistical significant reduction of CMT to 358,85±115,28 μm (p = 0.021) that was maintained at the 6th month, 315,22±89,46 μm (p = 0.008). The mean MV at months 3 and 6 was 9,92±1,15 mm3 (p = 0.071) and 9,30±1,14 mm3 (p = 0.0521) respectively, approaching marginal levels of significance when compared with baseline.
This study demonstrated that intravitreal FAc implant (Iluvien®) is effective and safe in non-naïve eyes with chronic DME. The results showed a significant and sustained decrease in CMT and MV. There was no statistically significant change in IOP. From present data in real-life setting at our site and recent data published from EARLY study, authors may advise the treatment with FAc earlier in non-naïve eyes with chronic DME.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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