drugset / Trial / NCT04856397

Ozurdex in Suboptimal Diabetic Macular Edema Patients

NCT04856397

Unknown 200 enrolled Uptown Eye Specialists
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary focus of this study is to understand the anatomic and visual outcomes of patients with refractory and suboptimal treatment response diabetic macular edema (DME) using anti-vascular endothelial growth factor (VEGF) to Ozurdex, an intravitreal dexamethasone implant. Secondly, investigators aim to understand the differences in cytokine profiles in patients who respond differently to intravitreal anti-VEGF versus Ozurdex. The importance of this study is to identify biomarkers that may help predict patients' response to different treatment protocols. Currently, Ozurdex is not covered by provincial health benefit plans for patients with DME. Our results may help improve access to care for those who have suboptimal results with or refractory to intravitreal anti-VEGF treatment.

Timeline

Start
2021-05-25
Primary completion
2021-08-30
Completion
2021-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic Intravitreal
Subject Dexamethasone Small molecule Intravitreal