Status:
COMPLETED
Intravitreal Bevacizumab and Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA)
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Macular edema is a leading cause of decreased visual acuity in patients with diabetic retinopathy1,2. Laser photocoagulation is the standard of care treatment for diabetic macular edema, based on ETD...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00997191
Start Date
October 1 2009
End Date
November 1 2011
Last Update
March 4 2013
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil