drugset / Trial / NCT02310295

Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema

NCT02310295

Completed 45 enrolled University of Sao Paulo
RandomizedParallel-groupOpen-labelTreatment

Summary

Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.

Timeline

Start
2009-01
Primary completion
2011-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody Intravitreal
Comparator Triamcinolone Acetonide Other / unclassified Intravitreal