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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema.

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Triamcinolone acetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bevacizumab<br> | Drug: Bevacizumab<br>* 1.25mg bevacizumab (0.05ml)<br>* Other names: 2.Avastin;|
| Experimental: Triamcinolone<br> | Drug: Triamcinolone acetonide<br>* 4.0 mg Triamcinolone acetonide injection<br>* Other names: 2. Kenalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic macular edema, intravitreal injection, Pharmacological treatment