Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)
This trial is active, not recruiting.
|Condition||diabetic macular edema|
|Treatments||intravitreal injection of 1,5 mg of bevacizumab, intravitreal injection of 4 mg of triamcinolone acetonide|
|Sponsor||University of Sao Paulo|
|Start date||April 2006|
|End date||April 2007|
|Trial identifier||NCT00468351, 154342005|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Central Macular Thickness, Best Corrected Visual Acuity
time frame: six months
Intraocular pressure; lens status
time frame: six months
Male or female participants at least 18 years old.
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
|Official title||Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema|
|Principal investigator||Rodrigo Jorge, MD, PhD|
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