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Panos Vouzounis, Simon Taylor, Usha Chakravarthy, Clare Bailey, Frank HJ Koch, João Sousa; Earlier intervention is associated with improved visual outcomes in patients with persistent or recurrent diabetic edema - Clinical insights from the ILUVIEN (fluocinolone acetonide) Registry Safety Study (IRISS). Invest. Ophthalmol. Vis. Sci. 2019;60(9):2630.
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Patients with DME who exhibit a suboptimal response to anti-VEGF agents are often treated with corticosteroids such as the ILUVIEN implant as it is believed that as DME progresses it becomes more inflammatory driven. However there is no strong consensus on optimal timing for the switch of drug class. Here we test the hypothesis that an earlier switch to steroid would improve outcomes.
The IRISS study (clinicaltrials.gov identifier NCT01998412) is an ongoing open label, observational registry study being conducted in the United Kingdom, Germany and Portugal in patients with DME that have been treated according to the European label. Visual acuity data (mean letter gains from baseline, achievement of ≥15 letters from baseline, achievement of 6/12 vision and stable/improved visual acuity) were collected in patients that had 3 years of follow-up after being treated with the FAc implant. Data was then divided into two groups – those with short-standing (DME-S; ≤3 years; n=37 eyes) and those with long-standing DME (DME-L; >3 years; n=156 eyes).
Mean age of the patients was 65.7±10.8 (mean±SD) years and the mean duration of DME was 4.54 years. At 3 years, the mean VA changes were 1.2±16.1 letters (P>0.05 versus baseline [52.6±18.0 letters]) in the DME-L group and 7.2±13.6 letters (P=0.033 versus baseline [51.7±19.9 letters]) in the DME-S group. Numerically, the DME-S group also had a greater percentage of patients achieving ≥15 letters than the DME-L group at year-3 (23.5% versus 17.6%) and gaining 6/12 vision (47.1% versus 27.1%). These numerical advantages were also evident at years 1 and 2. In keeping with these observations, the percentage of patients maintaining or experiencing an improvement in visual acuity favoured the DME-S group (i.e. 82.4% versus 68.2% at year 3 [DME-S versus DME-L]).
Data show that eyes with DME-S had an advantage in terms of visual acuity improvements versus DME-L. Findings support the hypothesis tested, that earlier treatment with the FAc implant was associated with better visual outcomes in patients with persistent or recurrent DME. Further research with a larger population is needed to confirm these findings.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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