Dexamethasone intravitreal implant (Ozurdex) in diabetic macular edema: real-world data versus clinical trials outcomes.

Abstract

AIM\nTo investigate the safety and efficacy of intravitreal dexamethasone implants (Ozurdex®/DEX) in patients with diabetic macular edema (DME) either naïve or non-naïve to anti-VEGF therapies who switched to DEX implant independent of response to anti-vascular endothelial growth factors (anti-VEGFs).\n\n\nMETHODS\nThis was an audit retrospective review of medical records of patients with DME who switched to the DEX intravitreal implant. Patients were divided into 2 groups: patients naïve to antiangiogenic therapy and patients who were previously treated with anti-VEGFs. Data regarding demographics, changes in mean best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) was collected over 6mo. The demographic data mean changes in BCVA, CMT, and IOP were compared. Six-month follow-up data of 47 patients (57 eyes), who either switched to DEX implant irrespective of response to previous treatments or were treatment naïve before receiving DEX implant, was collected.\n\n\nRESULTS\nImprovement in mean BCVA was observed from 1-4mo after injection with a decreased effect at month 6 as expected, with better outcomes in naïve compared to non-naïve patients. A statistically relevant decrease in mean CMT was observed during the follow-up period. An increase in mean IOP was observed in the first 2mo after DEX therapy. The mean number of injections of the overall population during the 6mo was 1.3. A subgroup analysis showed no relevant difference between phakic versus pseudophakic patients relative to measured outcomes. There was no cataract progression during the follow-up period and no adverse events reported.\n\n\nCONCLUSION\nThis real-life setting study shows that intravitreal DEX implant is effective and safe. The timings of greater therapeutic impact are concordant with previous studies and suggest that earlier treatment with corticosteroids may have an additional benefit in naïve patients.