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

Phase 3

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Other: Grid laser; Drug: Triamcinolone Acetonide; Drug: Bevacizumab

• Registration Number: NCT01572350
• Lead Sponsor: Hospital Universitario de Canarias

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grid laser	Grid laser	It's a reference standard as the treatment which is currently accepted for NTDDME
Triamcinolone 4 mg	Triamcinolone Acetonide	-
Bevacizumab	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Best-Corrected Visual Acuity (BCVA)	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 Outcome Measures

Name	Time	Method
To assess the safety of intravitreal Triesence (r)	Baseline, 3m, 6m and 12 months	Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability.
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 measure average change in mean central macular thickness (in microns) obtained by Optical Coherence Tomography (OCT) at each follow-up visits compared to the baseline visit in each of the three groups.
To assess the safety of intravitreal Avastin (r)	Baseline, 3m, 6m and 12 months	Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability
To assess the safety of intravitreal grid photocoagulation	Baseline, 3m, 6m and 12 months	Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability

Trial Locations

Locations (1)

Hospital Universitario Dr Negrín; 🇪🇸 Las Palmas de Gran Canaria, Spain