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Br J Ophthalmol. 2018 Sep 21. pii: bjophthalmol-2018-312284. doi: 10.1136/bjophthalmol-2018-312284. [Epub ahead of print]

Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries.

Author information

1
Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom u.chakravarthy@qub.ac.uk.
2
Ophthalmology Department, Royal Surrey County Hospital, Guildford, UK.
3
Clinic of Ophthalmology, Goethe University, Frankfurt am Main, Germany.
4
Ophthalmology Department, Leiria Hospital Center, Leiria, Portugal.
5
Bristol Eye Hospital, Bristol, UK.

Abstract

AIMS:

The ILUVIEN Registry Safety Study is an ongoing, multicentre, open-label, observational study collecting real-world data on the safety and effectiveness of the 0.2 µg/day fluocinolone acetonide (FAc) implant in patients treated according to the European label requirements.

METHODS:

Patients included in this analysis were treated for the licensed indication of chronic diabetic macular oedema (cDMO; that is, DMO that persists or recurs despite treatment). Data presented in the current analysis were collected from patient records up to 6 March 2017. Visual acuity (VA) data, including mean change in VA over time and at last observation, intraocular pressure (IOP) over the course of the study, IOP events, use of IOP-lowering therapy and cup:disc ratio were analysed. Information on additional DMO treatments post-FAc implant was also captured.

RESULTS:

Five hundred and sixty-three patients (593 eyes) were enrolled on the study. Mean IOP for the overall population remained within the normal range throughout follow-up and 76.7% of patients did not require IOP-lowering therapy following treatment with the FAc implant. Sixty-nine per cent of eyes did not require additional DMO treatments. Mean VA in the overall population increased from 51.9 letters at baseline to 55.6 letters at month 12, with a significant increase of 2.9 letters at last observation. Patients with short-term cDMO experienced greater VA gains than those with long-term cDMO.

CONCLUSIONS:

The results of this analysis are comparable with those of other studies, including the Fluocinolone Acetate for Macular Edema study. The study reinforces the good safety and effectiveness profile of FAc, and demonstrates the benefit of early FAc treatment.

KEYWORDS:

clinical trial; macula; pharmacology; retina

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Conflict of interest statement

Competing interests: UC is a speaker and advisory board member for Alimera Sciences, an advisory board member for Allergan, Bayer, Novartis and Roche, and has received grants from Bayer, Novartis and Roche. SRT reports financial relationships with GlaxoSmithKline and Novartis, and speaker honoraria, advisory boards and travel grants from Alimera Sciences, Allergan, Bayer, GlaxoSmithKline, Novartis and Santen. FHJK reports a commercial relationship with Alimera Sciences. JPCdS reports no conflicts of interest. CB reports financial support from Alcon, Alimera Sciences, Allergan, Bayer and Novartis.

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