Article
Earlier therapy with the fluocinolone acetonide (ILUVIEN) implant based on safety and effectiveness outcomes in the European IRISS registry study
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Authors
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Ramin Khoramnia
- Universitätsaugenklinik Heidelberg, Heidelberg
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Tunde Peto
- School of Medicine, Dentistry and Biomedical Sciences, Centre for Public Health, Belfast, UK
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Frank H. Johannes Koch
- Augenklinik, Goethe Universität Frankfurt, Frankfurt am Main
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Simon R. Taylor
- Department of Ophthalmology, University of Surrey, Guildford, UK
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Joao Paulo Castro de Sousa
- Ophthalmology Department, Leiria Hospital Center, Leiria, Portugal
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Lauren Hill
- Statistical Consultant, Bozeman, Montana, USA
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Clare Bailey
- Bristol Eye Hospital, Bristol, UK
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Usha Chakravarthy
- Centre for Public Health, Queens Universtity Belfast, Belfast, UK
| Published: | June 3, 2022 |
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Outline
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Purpose: Subgroup analysis describing outcomes in short- and long-term chronic diabetic macular edema (cDME) following fluocinolone acetonide (FAc) therapy.
Methods: European (31 UK sites, 11 in Germany and 5 in Portugal), multicentre, open-label, observational registry study of patients treated with the FAc implant for any reason. Patients treated with a FAc implant (2013–2017) were included and monitored until the last patient reached ≥3 years of follow-up. Participants with a cDME duration ≤3.6 years (n=319) were classified as ‘short-term’, and those with a duration of >3.6 years (n=322) as ‘long-term.’ Study parameters included: mean intraocular pressure (IOP), IOP events and changes in mean VA.
Results: Over 36 months, eyes with short-term cDME had a marginally lower frequency of IOP-related events compared with eyes with long-term cDME. At Month 36, eyes in the short-term cDME group experienced a sustained improvement in VA (+6.6 letters from a baseline of 52.9 letters) and this was still evident at Month 48 (+7.5 letters from baseline). In the long-term cDME group the VA change was lower at Month 36 (+1.8 letters from a baseline of 51.6 letters) and lost by Month 48 (-1.9 letters from baseline).
Conclusions: In eyes with short-term cDME, the frequency of IOP-related events were marginally lower and VA improvements were sustained, thus suggesting a positive benefit-to-risk profile in patients treated earlier with the FAc implant.
