Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00468351
First received: May 1, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

May 1, 2007
May 1, 2007
April 2006
Not Provided
Central Macular Thickness, Best Corrected Visual Acuity [ Time Frame: six months ]
Same as current
No Changes Posted
Intraocular pressure; lens status [ Time Frame: six months ]
Same as current
Not Provided
Not Provided
 
Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)
Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Diabetic Macular Edema
  • Procedure: Intravitreal Injection of 1,5 mg of bevacizumab
  • Procedure: Intravitreal injection of 4 mg of Triamcinolone acetonide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
Not Provided
April 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00468351
154342005
Yes
Not Provided
University of Sao Paulo
Not Provided
Study Chair: Rodrigo Jorge, MD, PhD HCFMRP-USP
Study Director: Rogério A Costa, MD, PhD Retina Diagnostic and Treatment Division, Hospital de Olhos de Araraquara, Araraquara
Principal Investigator: Rodrigo Jorge, MD, PhD HCFMRP-USP
University of Sao Paulo
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP