Impact of the Dexamethasone Implant on Slowing Diabetic Retinopathy Progression: Post Hoc Analysis of the MEAD Study.

Abstract

Purpose: To evaluate the effects of dexamethasone intravitreal implant (DEX) treatment on Diabetic Retinopathy Severity Scale (DRSS) scores and disease progression in patients with diabetic macular edema (DME).

Methods: The 3-year, randomized, phase 3 MEAD study evaluated DEX 0.35 and 0.7 mg versus sham (treatment at ≥6-month intervals) in patients with DME. This post hoc analysis used data from the sham and pooled DEX arms.

Results: The proportion of patients with ≥2-step DRSS score improvement was significantly higher after DEX treatment compared with sham at 24 months only (8.8% vs 4.2%, OR=2.1, P=0.016). Among those with ≥2-step DRSS score improvement, the time to first ≥2-step improvement was shorter with DEX (P<0.001; median 400 days with DEX versus 713 with sham). There were no significant differences between the DEX and sham groups in the proportion of patients who progressed from non-proliferative to proliferative DR, but among those who progressed, the time to progression was lengthened with DEX (P<0.001; median 531.1 days with DEX versus 191 with sham).

Conclusion: This post hoc analysis of MEAD study data showed that DEX treatment may potentially have a positive impact on DR by reducing disease severity and slowing progression in DR patients with central DME.