Retina (Philadelphia, Pa.) · 2025
IMPACT OF THE DEXAMETHASONE IMPLANT ON SLOWING DIABETIC RETINOPATHY PROGRESSION: Post Hoc Analysis of the MEAD Study.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Blinder Kevin J, Wykoff Charles C, Ferencz Joseph R, Ehlers Justis P, Fang Yixin, Lai Hongxin, Ogidigben Miller, López Francisco J
Аннотация
PURPOSE: To evaluate the effects of dexamethasone intravitreal implant (DEX) treatment on Diabetic Retinopathy Severity Scale scores and disease progression in patients with diabetic macular edema.
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 diabetic macular edema. This post hoc analysis used data from the sham and pooled DEX arms.
RESULTS: The proportion of patients with ≥2-step Diabetic Retinopathy Severity Scale 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 Diabetic Retinopathy Severity Scale score improvement, the time to first ≥2-step improvement was shorter with DEX ( P < 0.001; median 400 days with DEX vs. 713 with sham). There were no significant differences between the DEX and sham groups in the proportion of patients who progressed from nonproliferative to proliferative diabetic retinopathy, but among those who progressed, the time to progression was lengthened with DEX ( P < 0.001; median 531.1 days with DEX vs. 191 with sham).
CONCLUSION: This post hoc analysis of MEAD study data showed that DEX treatment may potentially have a positive impact on diabetic retinopathy by reducing disease severity and slowing progression in patients with diabetic retinopathy with central diabetic macular edema.
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 diabetic macular edema. This post hoc analysis used data from the sham and pooled DEX arms.
RESULTS: The proportion of patients with ≥2-step Diabetic Retinopathy Severity Scale 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 Diabetic Retinopathy Severity Scale score improvement, the time to first ≥2-step improvement was shorter with DEX ( P < 0.001; median 400 days with DEX vs. 713 with sham). There were no significant differences between the DEX and sham groups in the proportion of patients who progressed from nonproliferative to proliferative diabetic retinopathy, but among those who progressed, the time to progression was lengthened with DEX ( P < 0.001; median 531.1 days with DEX vs. 191 with sham).
CONCLUSION: This post hoc analysis of MEAD study data showed that DEX treatment may potentially have a positive impact on diabetic retinopathy by reducing disease severity and slowing progression in patients with diabetic retinopathy with central diabetic macular edema.