June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
The first European report of real-life clinical outcomes after 3 years of treatment with ILUVIEN® (fluocinolone acetonid) in patients with chronic diabetic macular edema (DME)
Author Affiliations & Notes
  • Albert J Augustin
    Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany
  • Jenny Atorf
    Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany
  • Footnotes
    Commercial Relationships   Albert Augustin, Alimera Sciences (R); Jenny Atorf, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 928. doi:
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    • Get Citation

      Albert J Augustin, Jenny Atorf; The first European report of real-life clinical outcomes after 3 years of treatment with ILUVIEN® (fluocinolone acetonid) in patients with chronic diabetic macular edema (DME). Invest. Ophthalmol. Vis. Sci. 2017;58(8):928.

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

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Abstract

Purpose : To report both efficacy and safety outcomes of chronic DME patients after 3 years of ILUVIEN® therapy.

Methods : This is a retrospective analysis of data collected until 25th of November 2016 from 3 patients from 3 centers in Germany. No eyes had prior macular laser or vitrectomy. During the 12 months prior to ILUVIEN® injection, a mean of 3 (range 0 to 6) intravitreal injections of anti-VEGF were administered. No intravitreal steroids have been applied. All patients were monitored at baseline and at 13 subsequent visits over a period of 36 months. Functional and structural responses were evaluated by means of BCVA change (using ETDRS letters) and central macular thickness (CMT) measurements. Safety outcomes were assessed regarding the need of treating raised intraocular pressure (IOP).

Results : At baseline, one of the treated eyes was phakic with cataract removal performed at day 226. Baseline mean BCVA was 38.2 (range 20 to 60) ETDRS letters and mean CMT was 599.3µm (range 576.0 to 643.9). After 36 months ILUVIEN® therapy, BCVA increased by +11.5 (range 0 to 20) letters on average and mean CMT decreased by -319.7µm (range -193.0 to -413.0). These changes were evident as early as month 4. In one patient IOP increased above 21mmHg and was effectively managed with IOP-lowering drops (first latanoprost then switch to 0.25% timolol) reducing IOP below 21 mmHg from day 86 onwards. In one eye, combined DME therapy (ILUVIEN® plus a single dexamethasone) was used to treat recurrent edema.

Conclusions : This is the first report showing that in routine clinical practice a single ILUVIEN® implant provides early and sustained improvement of BCVA and CMT reduction lasting up to 36 months, and that IOP increases were effectively managed with IOP-lowering drops.

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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