Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Bevacizumab; Drug: Triamcinolone acetonide

• Registration Number: NCT00874744
• Lead Sponsor: Universidade Federal de Goias

Brief Summary

The purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema.

Detailed Description

Comparison a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab regarding the ability of central macular thickness reduction. Secondary objectives are analysis of Visual Outcomes and variations on Intraocular Pressure. The patients data were statistically analyzed if there was a 24 week follow up completed.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Status Verified: 2009-03
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Last Update Submitted: 2009-03-31
• Study First Posted: 2009-04-02
• Last Update Posted: 2009-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Diabetic macular edema with central foveal measurement over 300 micrometers

Exclusion Criteria

• Glaucoma
• Vitreoretinal surgery
• Cataract Surgery less than 3 months prior inclusion
• Unilateral cataract surgery
• Uncontrolled Glycosylated Hemoglobin
• Previous Intraocular Injection
• Systemic Corticosteroids less than 1 month prior inclusion
• Macular ischemia at Fluorescein Angiography
• Cataract precluding fundus examination
• Active Proliferative Diabetic Retinopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bevacizumab	Bevacizumab	-
Triamcinolone	Triamcinolone acetonide	-

Primary Outcome Measures

Name	Time	Method
Comparison between the efficacy of a single intravitreal injection of 4.0mg of triamcinolone acetonide or 1.25mg of bevacizumab in the treatment of diabetic macular edema	6 months

Secondary Outcome Measures

Name	Time	Method
To compare Visual Acuity between the same drug in Initial visit, 4, 12 ans 24 weeks and Visual Acuity between two group of eyes treated with different drugs.	6 months
To compare Intraocular Pressure between the same drug in Initial visit, 4, 12 ans 24 weeks and Intraocular Pressure between two group of eyes treated with different drugs.	6 months