drugset / Trial / NCT07843849

Corticosteroid for Diabetic Macular Edema (DME) Study

NCT07843849 ↗

Phase 4 Recruiting 20 enrolled Vanderbilt University Medical Center
RandomizedSingle-groupOpen-labelTreatment

Summary

Our current goals include confirming inflammation mediators are biomarkers of DR and DME The Aim of this project is to measure aqueous PGE2 and inflammatory cytokines before and after treatment of DME with intravitreal corticosteroid injections. We want to continue the study for one more year as our initial data analysis from the original INSPIRE study shows a possible direct correlation between aqueous biomarkers and DME. We propose treating the DME with corticosteroid to assess the effect upon the intraocular cytokines with inflammation is suppressed.

Timeline

Start
2026-04-07
Primary completion
2028-03
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 0.7 mg Intravitreal
Comparator fluocinolone acetonide Other / unclassified 0.19 mg Intravitreal