Early Efficacy and Tolerance of The Intravitreal Implant of Dexamethasone (Ozurdex) for Refractory and Treatment-Naïve Diabetic Macular Edema: A Prospective Study About 40 Patients

Introduction: Dexamethasone implant has proven to improve visual and anatomic outcomes in patients with persistent DME or resistant to anti-VEGF therapy, with a good safety profile. Objective: Investigate the efficacy and safety of the dexamethasone implant after 2 months and compare the outcome between naïve and refractory patients. Methods: Monocentric prospective study from August 2022 to February 2023. Inclusion criteria were BCVA⩽ 0.3 logMar and ERC ⩾ 300 um secondary to OMD. Our primary endpoints were BCVA gain and ERC after 2 months in the naïve and non-naïve groups. Secondary endpoints were treatment side effects. Results: 40 eyes, 21 naïve and 19 non-naïve, were included in the study. The sex ratio M/F was 1.1, and the mean age was 65.4 years. 8 patients were pseudophakic. Mean BCVA was 1.01 logMar at inclusion and 0.71 logMar at M2. VA gain was higher and more prolonged in the naïve group. Mean ERC was 532 μm at inclusion and 298 μm at M2. Elevation of IOP was noted in 2 patients and was controlled with only toping hypotensive agents. No serious complications were observed. Conclusion: The dexamethasone implant is effective in the treatment of DME, with a significant gain in VA and reduction in CME in both groups, with a good tolerance profile. Better visual and anatomic outcomes were observed in the treatment-naïve group.