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

Randomized Multicenter Clinical Trial of Three Parallel Groups to Estimate the 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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Hospital Universitario de Canarias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
OTHER	Grid laser	Grid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT.
DRUG	Triamcinolone Acetonide	Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks
DRUG	Bevacizumab	Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-04-06
• Last updated: 2021-02-15

Locations

1 site across 1 country: Spain