Overview

Intravitreal Bevacizumab and Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA)

Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
0
Participant gender:
All
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, the purpose of this study is to evaluate the effects of intravitreal bevacizumab and intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Sao Paulo
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Treatments:
Bevacizumab
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Criteria
Inclusion Criteria:

- Clinically significant DME - by biomicroscopic evaluation with 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 20/40 or worse

- Central macular thickness greater than 275 µm on optical coherence tomography (OCT)

Exclusion Criteria:

- Glycosylated hemoglobin rate above 10%

- History of glaucoma or ocular hypertension

- 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

- Severe systemic disease

- Any condition affecting documentation or follow-up