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Review Diabetic Macular Oedema An Evidence-based Approach to Using Intravitreal Steroids in the Management of Diabetic Macular Oedema Mehmet Ozturk, Martin L Harris and Hemal Mehta Royal Free London NHS Foundation Trust, London, UK D iabetic macular oedema (DMO) is the leading cause of acquired visual loss in the working age population. The landscape for DMO treatment has changed significantly over the past decade. Macular laser has been reported to reduce the risk of moderate visual loss in seminal clinical trials from the 1980s, but relatively few patients achieved visual gain. With the advent of intravitreal pharmacotherapy it is now possible to achieve visual gains in the majority of patients. Intravitreal anti-vascular endothelial growth factor (VEGF) agents are now a first-line treatment option in centre-involving DMO. This review assesses clinical trial and more recent real-world evidence to guide clinicians as to when intravitreal steroids should be considered in the management of DMO. In particular, intravitreal steroids can be considered in pseudophakic patients, or those due to undergo cataract surgery, in patients unable to attend for regular intravitreal procedures, and non-responders to intravitreal anti-VEGF therapy. Assessing clinical trial data, the dexamethasone implant appears to have a more predictable intraocular rise profile than triamcinolone or fluocinolone with a lower requirement for incisional glaucoma surgery. There is a need for consensus regarding real-world outcome measures for intravitreal steroids in the management of DMO to allow easier comparison across studies.  Keywords Steroid, diabetic macular oedema, real-world evidence, clinical trials, triamcinolone, fluocinolone, dexamethasone Disclosure: Hemal Mehta is an invited member of the Allergan International Retinal Panel. He was also an investigator on the BEVORDEX randomised clinical trial. Mehmet Ozturk and Martin Harris have nothing to disclose in relation to this article. Compliance with Ethics: This study involves a review of the literature and did not involve any studies with human or animal subjects performed by any of the authors. Authorship: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit. Received: 11 May 2017 Accepted: 9 June 2017 Citation: European Ophthalmic Review, 2017;11(1):44–54 Corresponding Author: Hemal Mehta, Royal Free London NHS Foundation Trust, Pond Street, Hampstead, London, NW3 2QG, UK. E: HM@cantab.net Support: The publication of this article was supported by Allergan. The views and opinions expressed are those of the authors and do not necessarily reflect those of Allergan. 44 Diabetic macular oedema (DMO) is the leading cause of acquired visual loss in the working age population. 1 There are estimated to be 21 million people with DMO globally, 2 with numbers expected to rise as diabetes becomes more common and life expectancy improves. 3 The landscape for DMO treatment has changed significantly over the past decade. Macular laser photocoagulation was reported to be effective in reducing the rate of moderate visual loss in seminal large scale clinical trials such as the Early Treatment Diabetic retinopathy Study (ETDRS). 4 Management of centre-involving DMO was subsequently revolutionised with the introduction of intravitreal therapies such as corticosteroids and anti-vascular endothelial growth factor (anti- VEGF) inhibitors, where it was not only possible to prevent visual loss but also to potentially improve vision. 5,6 There is clinical trial evidence to support intravitreal steroid therapy (triamcinolone, fluocinolone or dexamethasone) as a treatment option for the management of DMO; however, local side-effects of accelerated cataract formation and raised intraocular pressure (IOP) need to be managed. 7 Intravitreal anti-VEGF therapy has become the mainstay of treatment for DMO, but the potential for increased rates of thromboembolic events in high risk populations, 8 insufficient treatment response in some patients 9 and the treatment burden 10 from frequent injections remain potential disadvantages. This review aims to supplement evidence from clinical trials of intravitreal steroid therapy with more recent real-world data to provide guidance on their role in the management of DMO. Triamcinolone Clinical trials The Triamcinolone for Diabetic Macular Oedema (TDMO) study by Gillies et al. was a 2-year, randomised, double-masked, placebo-controlled trial of intravitreal triamcinolone in 69 eyes (43 patients) with DMO unresponsive to macular laser therapy (MLT). 11 The patients were split into the intravitreal triamcinolone acetonide (IVTA) group (n=34 eyes), receiving 4 mg of IVTA (mean 2.6 injections over 2 years), and the control group (n=35 eyes), who received subconjunctival saline placebo injections (mean 1.8 injections over 2 years). The primary outcome measure was increase in best corrected visual acuity (BCVA) by ≥5 logMAR letters. BCVA increase was observed in 56% in the IVTA group and 26% in the control group (p=0.006). Furthermore, at 2 years the IVTA group had a mean 3.1 letter gain in BCVA whereas the control group had a 2.9 letter loss. With regard to central macular thickness (CMT), the IVTA group had a decrease of 125 µm compared to 75 µm in the control group. In terms of adverse events, cataract surgery was required in 54% of patients in the IVTA group compared with 0% in the control group. IOP rise of >5 mmHg was observed in TOU C H ME D ICA L ME D IA