REAL-LIFE STUDY IN DIABETIC MACULAR EDEMA TREATED WITH DEXAMETHASONE IMPLANT: The Reldex Study.

Abstract

To evaluate the efficacy and safety of intravitreal implant of dexamethasone (Ozurdex) in diabetic macular edema in real-life practice. 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. 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 μm to 289 μm at Month 2 (P < 0.001), 370 μm at Month 12 (P < 0.001), 377 μm at Month 24 (P = 0.004), and 280 μm 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. 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.