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.

Hospital Universitario de Canarias1 site in 1 country105 target enrollmentOctober 2010

ConditionsDiabetic Macular Edema

InterventionsBevacizumab Grid laser Triamcinolone Acetonide

DrugsTriamcinolone Acetonide Bevacizumab

Overview

Phase: Phase 3
Intervention: Bevacizumab
Conditions: Diabetic Macular Edema
Sponsor: Hospital Universitario de Canarias
Enrollment: 105
Locations: 1
Primary Endpoint: Best-Corrected Visual Acuity (BCVA)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

December 2013

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Universitario de Canarias

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Bevacizumab

Intervention: Bevacizumab

Grid laser

It's a reference standard as the treatment which is currently accepted for NTDDME

Intervention: Grid laser

Triamcinolone 4 mg

Intervention: Triamcinolone Acetonide

Outcomes

Primary Outcomes

Best-Corrected Visual Acuity (BCVA)

Time Frame: 12 months

To evaluate the effect on best-corrected visual acuity (BCVA) of intravitreal triamcinolone (Triesence ®) or bevacizumab (Avastin ®) in combination with grid laser therapy compared to grid laser therapy alone after 12 months of treatment, in diabetic patients with not tractional diffuse macular edema (NTDDEM)

Secondary Outcomes

To assess the safety of intravitreal Triesence (r)(Baseline, 3m, 6m and 12 months)
To measure average change in mean central macular thickness in each group.(Baseline and 3, 6 and 12 months after the treatment was initiated.)
To assess the safety of intravitreal Avastin (r)(Baseline, 3m, 6m and 12 months)
To assess the safety of intravitreal grid photocoagulation(Baseline, 3m, 6m and 12 months)