Status:
UNKNOWN
Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)
Lead Sponsor:
University of Sao Paulo
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00468351
Start Date
April 1 2006
End Date
April 1 2007
Last Update
May 2 2007
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14049-900