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

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ClinicalTrials.gov Identifier: NCT00468351
Recruitment Status : Unknown
Verified April 2007 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : May 2, 2007
Last Update Posted : May 2, 2007
Information provided by:
University of Sao Paulo

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 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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Procedure: Intravitreal Injection of 1,5 mg of bevacizumab Procedure: Intravitreal injection of 4 mg of Triamcinolone acetonide Phase 1

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema
Study Start Date : April 2006
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Primary Outcome Measures :
  1. Central Macular Thickness, Best Corrected Visual Acuity [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Intraocular pressure; lens status [ Time Frame: six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468351

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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00468351    
Other Study ID Numbers: 154342005
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: May 2, 2007
Last Verified: April 2007
Keywords provided by University of Sao Paulo:
macular edema
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action