Evaluation of the clinical effectiveness in routine practice of fluocinolone acetonide 190 µg intravitreal implant in people with diabetic macular edema

Abstract

Objective: The aim of the Iluvien Clinical Evidence study in the UK (ICE-UK) was to assess the real-world effectiveness of fluocinolone acetonide (FAc) 190 µg intravitreal implant for the treatment of clinically significant chronic diabetic macular edema (DME) in routine clinical practice.

Methods: This retrospective study collected data from patient medical records in 13 ophthalmology centers for people with DME prescribed FAc intravitreal implant between April 1, 2013 and April 15, 2015. Visual acuity (VA) and intraocular pressure (IOP) measurements were collected for 12 months prior to and after implant.

Results: Two hundred and eight people, contributing 233 eyes, treated with FAc implant were included. Mean age was 68.1 years and 62% were male. In the 12 months prior to FAc implant, VA declined. Median (interquartile range, IQR) VA was 0.66 (0.48–1.00) LogMAR units (equivalent to 52.0 ETDRS letters) at implant, improving to 0.60 (0.38–0.90) LogMAR units (55.0 letters) at 12 months post-implant (p < 0.001). In total, 44%, 30%, and 18% of people achieved an improvement in ETDRS score of ≥5, ≥10, and ≥15 letters, respectively, over the same period. A small but significant (p < .001) increase in median IOP was observed (median = 15.0, IQR = 13.0–18.0 mmHg at implant to 18.0, 15.0–21.0 mmHg at 12 months). In the 12 months following implant, additional IOP-lowering therapy was prescribed in 15% of subjects previously not requiring such therapy.

Conclusion: Following FAc implant, an overall significant improvement in VA was observed over a period of 12 months, accompanied by a significant but small increase in IOP.

Keywords:

• Fluocinolone acetonide
• diabetic macular edema
• visual acuity
• intraocular pressure
• retrospective

Transparency

Declaration of funding

This study was supported by Alimera Sciences, the manufacturer of Iluvien 190 µg intravitreal implant, who designed the study and commented on the manuscript.

Declaration of financial/other relationships

SH is employed by and CJC is a director of Pharmatelligence, a research consultancy receiving funding from Alimera Sciences for the submitted work and from other healthcare related organizations. DRO has received sponsorship from Sanofi to attend the American Diabetes Association Meeting, San Diego, June 2017. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.

Acknowledgments

The authors thank Annette Beiderbeck of Alimera Sciences for designing the study and commenting on the manuscript. We acknowledge the contributions of the staff at the following ICE-UK study centres: New Cross Hospital, Wolverhampton; Maidstone Hospital, Maidstone; Bristol Eye Hospital, Bristol; Royal Victoria Hospital, Belfast; The James Cook University Hospital, Middlesborough; University Hospital, Norfolk; Sunderland Eye Infirmary, Sunderland; Royal Hallamshire Hospital, Sheffield; Royal Surrey County Hospital, Guildford; Queen Elizabeth Hospital, Birmingham; Moorfields Eye Hospital, London; Sandwell General Hospital, West Bromwich; and Royal Free Hospital, London. Particularly, the authors thank Prof Yit Yang who was instrumental in project development, selection of clinically relevant endpoints, development of the protocol and study design. We also thank Prof Yit Yang for his comments on the draft manuscript. The authors thank SVMPharma for collating the data, Dafydd Williams for initial data preparation and analysis, and Sara Jenkins-Jones for her editorial work.

Previous presentations

These results have been presented at The Association for Research in Vision and Ophthalmology (ARVO) 2017 meeting, International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting 2017, 17th EURETINA Congress 2017, and the Royal College of Ophthalmology (RCOphth) Congress 2017.