Overview

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
Phase phase 1
Sponsor University of Sao Paulo
Start date April 2006
End date April 2007
Trial identifier NCT00468351, 154342005

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
Central Macular Thickness, Best Corrected Visual Acuity
time frame: six months

Secondary Outcomes

Measure
Intraocular pressure; lens status
time frame: six months

Eligibility Criteria

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

Additional Information

Official title Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema
Principal investigator Rodrigo Jorge, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2007.
Information provided to ClinicalTrials.gov by University of Sao Paulo.