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.
- clinical trial
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Contributors All authors made substantial contributions to conception, design, analysis and interpretation of data and contributed to writing the article and approved the current version.
Funding This study was funded by Alimera Sciences. Medical writing assistance was provided by Helios Medical Communications, Alderley Edge, Cheshire, UK and funded by Alimera Sciences.
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.
Patient consent Obtained.
Ethics approval UK: HSC Research Ethics Committee 2 (14/NI/0002). Portugal: Comissão de Ética para a Saúde da AIBILI (N/A), CES IRL (N/A), CEIC (2014-EO-03), CES Hospital Vila Franca de Xira (N/A), CES Centro Hospitalar do Porto (2015.130 (117-DEFI/107-CES)), CES Centro Hospitalar de Leiria (N/A), CES Centro Hospitalar de Setúbal (0015/2016F), CES Centro Hospitalar de Lisboa Ocidental, EPE (N/A), Comissão de Ética da U. L. S. Matosinhos (36/CE/JAS). Germany: Ethik kommission Landesӓrztekammer Rheinland-Pfalz (837.501.13 (9186-F)), Ethik kommission Universitӓts Klinikum Tubingen (088/2014BO2), Ethik kommission Rheinische Friedrich-Wilhelms-Universitӓt (044/14), Ethik kommission der ӓrztekammer Hamburg (N/A), Ethik kommission Universitӓt Leipzig (N/A), Ethik kommission Universitӓt Dusseldorf (4585), Ethik kommission der ӓrztekammer Berlin (N/A), Ethik kommission Heidelberg (S-058/2014).
Provenance and peer review Not commissioned; externally peer reviewed.
Author note Trial locations: UK: Moorfields Eye Hospital, Queen's University Belfast, Gloucestershire Royal Hospital, Frimley Park Hospital, Heart of England NHS Foundation Trust, King’s College Hospital, Royal Surrey County Hospital, Imperial College London, Central Manchester University Hospitals, Plymouth Hospitals, Sheffield Teaching Hospitals, Sandwell and West Birmingham Hospitals, University Hospitals Birmingham, James Paget University Hospitals, City Hospitals Sunderland, Wrightington Wigan and Leigh Eye Unit, University Hospitals Leicester, Leighton Hospital, East Kent University Hospital, Portsmouth Hospitals, Royal Free Hospital London, The Royal Wolverhampton NHS Trust, Calderdale Hospital, Aintree University Hospital, Bristol Eye Hospital, Hull East Yorkshire Hospital, Queen’s Hospital, Maidstone Hospital, Royal Derby Hospital, Whipps Cross University Hospital, Norfolk and Norwich University Hospital; Germany: University Mainz, STZ Eyetrial, University of Bonn, Hamburg-Eppendorf, Eye Hospital Leipzig, Eye Centre Spreebogen, University of Heidelberg, Universitätsklinikum Carl Gustav Carus, Universitätsklinikum des Saarlandes; Portugal: AIBILI, Instituto de Retina e Diabetes Ocular de Lisboa, Santo Antonio, Hospital Leiria, Unidade Local de Saude de Matosinhos.