REAL-LIFE STUDY IN DIABETIC MACULAR EDEMA TREATED WITH DEXAMETHASONE IMPLANT: The Reldex Study. Issue 4 (April 2017)

• Record Type: Journal Article
• Authors: Malclès, Ariane; Dot, Corinne; Voirin, Nicolas; Agard, Émilie; Vié, Anne-Laure; Bellocq, David; Denis, Philippe; Kodjikian, Laurent
• Is Part Of: Retina. Volume 37:Issue 4(2017:Apr.)
• Publication Date: 2017-04
• Subjects: central macular thickness -- corticosteroids -- dexamethasone implant -- diabetic macular edema -- diabetic retinopathy -- ozurdex; Retina -- Diseases -- Periodicals; Retinal Diseases; Vitreous Body; 617.735
• DOI: 10.1097/IAE.0000000000001234
• Languages: English
• ISSNs: 0275-004X

Abstract

Abstract : 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 μ m to 289 μ m at Month 2 ( P < 0.001), 370 μ m at Month 12 ( P < 0.001), 377 μ m at Month 24 ( P = 0.004), and 280 μ m 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. Abstract : In this retrospective real-life study, we reviewed 128 eyes of 89 patients with diabetic macular edema. The proportion of eyes with a gain of ≥15 letters from baseline was 25.4% at Month 36. Ozurdex administrated in real-life conditions produced long-term meaningful benefits with a good safety profile.