April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Efficacy and Safety of ILUVIEN® (Fluocinolone Acetonide [FAc] Intravitreal Insert) for the Treatment of Diabetic Macular Edema
Author Affiliations & Notes
  • Andrew N. Antoszyk
    Retina, Charlotte EEN&T Associates, Charlotte, North Carolina
  • FAME Investigators
    Retina, Charlotte EEN&T Associates, Charlotte, North Carolina
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 6645. doi:
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    • Get Citation

      Andrew N. Antoszyk, FAME Investigators; Efficacy and Safety of ILUVIEN® (Fluocinolone Acetonide [FAc] Intravitreal Insert) for the Treatment of Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6645.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : To determine the efficacy and safety of a nonbioerodible drug delivery system that provides a sustained, submicrogram dose of FAc with near zero-order release kinetics. Efficacy and safety of 2 doses (0.2 µg/day and 0.5 µg/day) were compared with sham control in patients with diabetic macular edema (DME) over 36 months.

Methods: : The FAME (Fluocinolone Acetonide in Diabetic Macular Edema) program consisted of 2 identical, randomized, phase 3, double-masked, sham-controlled, multicenter, parallel-group trials evaluating FAc intravitreal inserts in DME patients who had received prior macular laser treatment. A total of 956 patients were randomly assigned to either 0.2 µg/day FAc (n = 376), 0.5 µg/day FAc (n = 395), or sham control (n = 185). The primary endpoint was the proportion of patients with ≥ 15-letter gain in BCVA at month 24. Total study duration was 36 months.

Results: : Significantly more patients in the 0.2 µg/day FAc group experienced ≥ 15-letter vision gain at 24 months vs control (28.7% vs 16.2%, respectively[P = .002]). This effect was maintained over 36 months (28.7% vs 18.9%, respectively[P = .018]). Rapid and sustained improvement in mean center point thickness was seen following treatment with the FAc inserts, which remained significant at 36 months. Significant improvements from baseline in best corrected visual acuity (BCVA) letter score were also seen at 36 months. A majority of patients achieved these effects with 1 study treatment (71.4%, 74.4%, and 70.7%, respectively for sham control, 0.2 µg/day FAc, and 0.5 µg/day FAc). By 36 months, 80.0 and 87.2% of phakic patients in the 0.2 and 0.5 µg/day FAc groups respectively underwent cataract surgery vs 27.3% of phakic controls. 18.4 and 22.9% of patients in the 0.2 and 0.5 µg/day FAc groups respectively experienced an IOP > 30 mm Hg at any point in the study vs 4.3% of sham control patients; 4.8 and 8.1% of patients in the 0.2 and 0.5 µg/day FAc groups required IOP-lowering surgery vs 0.5% for controls, respectively.

Conclusions: : Based on the results of the FAME program, the 0.2 µg/day FAc (ILUVIEN) has been submitted for regulatory approval. ILUVIEN significantly improves visual acuity and anatomical outcomes in DME patients with a low risk of incisional procedures for increased IOP.

Clinical Trial: : http://www.clinicaltrials.gov NCT00344968

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • diabetic retinopathy • edema 
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