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Diabetic Macular Oedema Case Study The Treatment of Diabetic Macular Oedema with ILUVIEN ® Intravitreal Implant Following Prior Anti-VEGF Therapy – Case Study Fahd Quhill Consultant Ophthalmologist, Royal Hallamshire Hospital, Sheffield, UK Abstract Diabetic macular oedema (DMO) is the main cause of vision loss in diabetic retinopathy. The ILUVIEN ® intravitreal implant, which contains fluocinolone acetonide and is administered by injection into the vitreous cavity, should be considered if the patient is not responding to anti-vascular endothelial growth factor (VEGF) therapy, and the patient fulfils the recommendations of the National Institute for Health and Care Excellence (NICE) Technology Appraisal 301. The efficacy and safety of the ILUVIEN implant has been demonstrated in clinical studies, and a pre-planned subgroup analysis has shown that it is particularly beneficial in patients with chronic DMO. This case study is the first report in the UK of the effectiveness of the ILUVIEN implant in a patient in whom therapy with ranibizumab did not result in sustained improvements in terms of visual outcomes and foveal thickness. Keywords Corticosteroids, ILUVIEN ® , fluocinolone acetonide, diabetic macular oedema (DMO) Disclosure: Fahd Quhill has attended advisory boards and speaker engagements and has been remunerated for these by Alimera Sciences. Acknowledgements: Editorial assistance was provided by Catherine Amey at Touch Medical Media London, UK. I also thank my Consultant Ophthalmic colleagues, Chris Brand and Nachi Acharya, who contributed to the management of this case. Compliance with Ethics Guidelines: All procedures were followed in accordance with the responsible committee on human experimentation and with the Helsinki Declaration of 1975 and subsequent revisions. Informed consent was received from the patient involved in this case study. Received: 21 October 2014 Accepted: 17 November 2014 Citation: European Ophthalmic Review, 2014;8(2):140–4 Correspondence: Fahd Quhill, Department of Ophthalmology, Royal Hallamshire Hospital, Glossop Road, Sheffield, South Yorkshire, S10 2JF, UK. E: fahd.quhill@sth.nhs.uk Support: The publication of this article and editorial assistance was funded by Alimera Sciences Ltd. The views and opinions expressed in the article are those of the authors and not necessarily those of Alimera Sciences Ltd. The International Diabetes Federation (IDF) estimated that 8.3  % of adults (or 382 million) had diabetes in 2013. 1 This is significantly higher than previous estimates (2.8  % or 171 million adults). 2 Diabetic retinopathy (DR) is a potentially sight-threatening disease affecting the retinal microvasculature and associated with prolonged hyperglycaemia and other conditions linked to diabetes mellitus such as hypertension. 3 DR is a chronic progressive disease with a prevalence of 34.6  %. 4 The prevalence of DR and new cases of DR varies by country with prevalence ranging from 10  % in Norway to 61  % in South Africa and newly diagnosed cases ranging from 1.5 % in African Americans to 31 % in China. 5 DR is a major cause of vision loss and blindness. Global vision loss occurs through the growth of new vessels, leading to intraocular haemorrhage and, in some cases, retinal detachment. Central vision loss is due to localised damage to the macula/fovea of the eye 3 as occurs in diabetic macular oedema (DMO) when the macula swells as fluid accumulates. DMO leads to vision loss and blindness in around 20 % of patients with DR. 5 These rates are set to rise, with diabetes set to increase to in excess of 592 million within the next 25 years. 1 Pathophysiology of Diabetic Macular Oedema Numerous physiological and molecular factors, including angiogenesis, inflammation and oxidative stress, are involved in DMO pathogenesis. 6 140 At early disease stages, vascular endothelial growth factor (VEGF) is a major factor in driving retinal changes whereas in chronic diseases, such as DMO, heightened inflammation plays a more important role. 7,8 Multiple inflammatory cytokines, such as interleukin (IL)-1β, IL-6, IL-8, monocyte chemoattractant protein-1 (MCP-1), interferon-gamma- inducible protein (IP-10) and VEGF, are upregulated as the severity of DR increases. 9 DMO is multi-factorial disease and steroids can provide an effective therapeutic option as they target multiple factors in DMO. 10 The ILUVIEN Intravitreal Implant ILUVIEN is an intravitreal implant containing 190 µg of fluocinolone acetonide (FAc implant). It measures 3.5 mm in length and 0.37 mm in width, and is injected into the vitreous cavity using a 25-gauge needle. The implant releases 0.2 µg/day of fluocinolone acetonide. 11 FAc implant is a multi-factorial therapy that offers continuous low-dose therapy for up to 36 months with a single injection. 12 The efficacy and safety of FAc implant has been examined in the Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Implants in Patients with DMO (FAMOUS) and Fluocinolone Acetonide for Diabetic Macular Edema (FAME) clinical trials. 12–15 Based on the clinical trial evidence, FAc implant is indicated for treatment of visual impairment due to chronic DMO that is considered insufficiently responsive to available therapies. FAc implant was launched in the UK and Germany in early 2013 and is currently licensed in the UK, Germany, Austria, France, Portugal, Spain, Italy, Norway, Sweden and © Touc h ME d ic al ME d ia 2014