REAL-LIFE STUDY IN DIABETIC MACULAR EDEMA TREATED WITH DEXAMETHASONE IMPLANT The Reldex Study ARIANE MALCLÈS, MD,* CORINNE DOT, MD, PHD,†‡ NICOLAS VOIRIN, PHD,* ÉMILIE AGARD, MD,†‡ ANNE-LAURE VIÉ, MD,* DAVID BELLOCQ, MD,* PHILIPPE DENIS, MD, PHD,* LAURENT KODJIKIAN, MD, PHD* Purpose: To evaluate the efficacy and safety of intravitreal implant of dexamethasone (Ozurdex) in diabetic macular edema in real-life practice. Methods: In this bicentric retrospective study, the authors reviewed 128 eyes of 89 patients. Main outcome measures included changes in best-corrected visual acuity, central macular thickness, time to retreatment, and incidence of adverse effects. Linear mixed- effects models were used to study changes in best-corrected visual acuity and central macular thickness over the 3-year follow-up. Results: Best-corrected visual acuity increased by a mean of 3.6 letters at Month 2 (P = 0.005), 4.2 letters at Month 12 (P = 0.006), 5.3 at Month 24 (P = 0.007), and 9.5 letters at Month 36 (P = 0.023). The proportion of eyes achieving at least a 15-letter improvement from baseline was 25.4% at Month 36. Central macular thickness decreased from 451 mm to 289 mm at Month 2 (P , 0.001), 370 mm at Month 12 (P , 0.001), 377 mm at Month 24 (P = 0.004), and 280 mm at Month 36 (P = 0.001). A mean of 3.6 injections were administered over the 3-year follow-up. Ten percent of eyes developed a transient increase in intraocular pressure (IOP $ 25 mmHg), and cataract was removed from 47% of phakic eyes. Conclusion: This large case series study showed favorable 3-year outcomes when using Ozurdex to treat diabetic macular edema. Intravitreal Ozurdex provides substantial long- term benefits in the treatment of diabetic macular edema in real-life. RETINA 37:753–760, 2017 D iabetic macular edema (DME) is the main cause of visual loss in diabetic retinopathy. 1 For a long time, laser photocoagulation has been considered as the gold standard for treating DME. 2 In recent years, using intravitreal anti-vascular endothelial growth factor (VEGF) agents to treat DME has been shown to be beneficial. 3,4 There has also been interest in using cor- ticosteroids to treat DME. By blocking VEGF, inflam- matory cytokines, and prostaglandins, corticosteroids have significant antiinflammatory, antipermeability, and antiangiogenic effects. 5 Although intravitreal injection of triamcinolone has been shown to result in significantly improved func- tional and anatomical outcomes, its use has been drastically reduced because of safety concerns (potential retinal toxicity, intraocular pressure (IOP) elevation, and progression of cataract). 6,7 The dexamethasone implant Ozurdex (Allergan, Irvine, CA) is a novel approach recently approved for the treatment of DME. 8 The purpose of our study was to evaluate the efficacy and safety profile of intravitreal dexametha- sone implant in eyes with DME in real-life conditions. From the *Department of Ophthalmology, Croix-Rousse Univer- sity Hospital, Hospices Civils de Lyon, UMR-CNRS 5510 Matéis, University of Medicine Lyon 1, Lyon, France; †Department of Oph- thalmology, Desgenettes Military Hospital, Lyon, France; and ‡French Military Health Service Academy, Val de Grâce, Paris, France. C. Dot is a consultant for Bayer, Alcon, Allergan, and Novartis. N. Voirin is an independent biostatistician paid by Acropol, a non- profit organization (L. Kodjikian). P. Denis is a consultant for Allergan. L. Kodjikian is a consultant for Alcon, Allergan, Alimera, Bayer, Novartis and Théa. None of the remaining authors have any conflicting interests to disclose. Reprint requests: Laurent Kodjikian, MD, PhD, Department of Ophthalmology, Croix-Rousse University Hospital, Hospices Civils de Lyon, 103, Grande Rue de la Croix-Rousse, 69317 Lyon Cedex 04, France; e-mail: kodjikian.laurent@wanadoo.fr 753