July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Real-world outcomes from the 3-year European ILUVIEN (0.19 mg fluocinolone acetonide implant) RegIstry Safety Study (IRISS)
Author Affiliations & Notes
  • Frank HJ Koch
    Retina and Vitreous, University Eye Clinic Frankfurt / M., Frankfurt am Main, HE, Germany
  • Usha Chakravarthy
    Queen’s University, Belfast, United Kingdom
  • Ramin Khoramnia
    IVCRC, university Eye Clinic Heidelberg, Heidelberg, BW, Germany
  • Simon Taylor
    Department: Ophthalmology, Royal Surrey County Hospital, Guildford, United Kingdom
  • Clare Bailey
    Bristol Eye Hospital, Bristol, United Kingdom
  • João Sousa
    Oftalmologia pelo Hospital da Universidade de Coimbra, Coimbra, Portugal
  • Footnotes
    Commercial Relationships   Frank Koch, Alimera Sciences (F), Bayer (F), Bayer (R), Novartis (R), Novartis (F); Usha Chakravarthy, Alimera Sciences (R), Allergan (R), Bayer (R), Bayer (F), Novartis (F), Novartis (R), Roche (R), Roche (F); Ramin Khoramnia, Alimera Sciences (F), Allergan (R), Bayer (F), Bayer (R), Novartis (R), Novartis (F), Roche (F); Simon Taylor, Alimera Sciences (R), Allergan (R), Bayer (R), GlaxoSmithKline (F), GlaxoSmithKline (R), Novartis (F), Novartis (R), Santen (R); Clare Bailey, Alcon (F), Alimera Sciences (F), Allergan (R), Allergan (F), Bayer (F), Bayer (R), Novartis (F), Novartis (R); João Sousa, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 2622. doi:
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      Frank HJ Koch, Usha Chakravarthy, Ramin Khoramnia, Simon Taylor, Clare Bailey, João Sousa; Real-world outcomes from the 3-year European ILUVIEN (0.19 mg fluocinolone acetonide implant) RegIstry Safety Study (IRISS). Invest. Ophthalmol. Vis. Sci. 2019;60(9):2622.

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

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Abstract

Purpose : To report on the 3 year safety and effectiveness findings from the ILUVIEN registry safety study (IRISS)

Methods : IRISS study (clinicaltrials.gov identifier NCT01998412) is a post-authorisation observational open label, registry study of the 0.19 mg fluocinolone acetonide (FAc) implant in diabetic macular edema (DME) and is being conducted in the United Kingdom, Germany and Portugal. It was commissioned by the European Medical Agency and designed to collect real-world data following FAc implantation in patients treated according to the European label. Data were extracted in September 2018 from 182 patients (209 eyes) with 3 years of monitoring post-treatment with the FAc implant. Safety was assessed in terms of the occurrence of intra-ocular pressure (IOP) events and their management. Effectiveness was determined from changes in stable / improved best-recorded visual acuity (BRVA) and the percentage of patients achieving 6/12 vision.

Results : Mean age of the patients was 65.7±10.8 (mean±SD) years and the duration of DME was 4.54 years. The majority (87.6%) of eyes that received the FAc implant were pseudophakic. Mean IOP was 14.9±3.4 mmHg at baseline and remained below 21 mmHg during the 3 year period. Topical IOP-lowering drops were required in 35.4% of eyes to control elevation in pressure and 10 eyes required surgery. The change in cup-to-disc ratio from baseline to 36 was marginal +0.07±0.14. Following implantation, mean VA improved / was maintained in 71% of eyes at year 3 and 31.1% achieved 6/12 VA compared to 17.8% at baseline.

Conclusions : Patients with DME with suboptimal response to predominantly anti VEGF agents and subsequently treated with the FAc implant experienced rises in IOP similar to those reported in the pivotal FAME trials. In addition, functional improvements were also in accord with those observed in FAME.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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