Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)

Study Overview
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Brief Summary
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Intravitreal triamcinolone has been effective for central macular thickness reduction and concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is a very effective inducer of permeability, being 50.000 times more potent than histamine, and may exert its effect on retinal vascular permeability by altering tight-junctions proteins, such as occluding and VE-cadherin. Based on these principles, there is a rationale for anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as diabetic macular edema. Therefore, we conducted a randomized, prospective study to compare the efficacy and safety of intravitreal triamcinolone acetonide and intravitreal bevacizumab injection for refractory diffuse DME.

Official Title
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Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Procedure: Intravitreal Injection of 1,5 mg of bevacizumab
* Procedure: Intravitreal injection of 4 mg of Triamcinolone acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Refractory diffuse DME (defined herein as clinically significant DME [by biomicroscopic evaluation] unresponsive to focal laser photocoagulation [performed at least 3 months before evaluation] and generalized breakdown of the inner blood-retina barrier with diffuse fluorescein leakage involving the foveal center and most of the macular area on fluorescein angiography), Snellen logarithm of minimum angle of resolution (LogMAR) BCVA equivalent of 20/40 or worse, and 3) central macular thickness (CMT) greater than 300µm on optical coherence tomography (OCT) Exclusion Criteria: Aphakic or pseudophakic eyes, Glycosylated hemoglobin (Hb A1C) rate above 10%, History of glaucoma or ocular hypertension, Loss of vision as a result of other causes, Systemic corticoid therapy,. History of thromboembolic event (including myocardial infarction or cerebral vascular accident); Major surgery within the prior 6 months or planned within the next 28 days; Uncontrolled hypertension (according to guidelines of the seventh report of the joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC-7]);16 Known coagulation abnormalities or current use of anticoagulative medication other than aspirin; Severe systemic disease; or Any condition affecting follow-up or documentation

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intravitreal Injection of 1,5 mg of bevacizumab|nan|
|Procedure: Intravitreal injection of 4 mg of Triamcinolone acetonide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Macular Thickness, Best Corrected Visual Acuity |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure; lens status |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bevacizumab, diabetes, intravitreal, macular edema, triamcinolone, VEGF