drugset / Trial / NCT04362241

DEXTENZA VS. PREDNISOLONE ACETATE 1% Macular Edema With Diabetic Retinopathy After Cataract Surgery

NCT04362241

Phase 4 Unknown 30 enrolled Ophthalmic Consultants of the Capital Region
RandomizedParallel-groupOpen-labelTreatment

Summary

The complicated schedules for administering topical steroid eye drops combined with forgetfulness and physical difficulties instilling the drops may compromise compliance; which in turn could increase the risk for secondary complications such as PME post-cataract surgery, especially in a high-risk diabetic population. Dextenza, a sustained- release steroid insert, could help preclude adherence difficulties and provide better bioavailability, being as effective as, or more effective than steroid drops in preventing PME. The aim of this study is to assess the incidence of PME in diabetic patients undergoing cataract surgery when comparing the Dextenza insert to topical prednisolone acetate 1% drops.

Timeline

Start
2020-08-07
Primary completion
2022-02
Completion
2022-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisolone Other / unclassified 1 % Other

Indications