drugset / Trial / NCT01572350

Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema

NCT01572350

Phase 3 Completed 105 enrolled Hospital Universitario de Canarias
RandomizedParallel-groupOpen-labelTreatment

Summary

This clinical trial is designed to investigate differences in terms of efficacy (mean change in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3 therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.

Timeline

Start
2010-10
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 1.25 mg Intravitreal
Subject Triamcinolone Acetonide Other / unclassified 4 mg