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
  Purpose

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 Intervention Phase
Diabetic Macular Edema
Procedure: Intravitreal Injection of 1,5 mg of bevacizumab
Procedure: Intravitreal injection of 4 mg of Triamcinolone acetonide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

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

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

Study Start Date: April 2006
Estimated Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00468351

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00468351     History of Changes
Other Study ID Numbers: 154342005
Study First Received: May 1, 2007
Last Updated: May 1, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
bevacizumab
diabetes
intravitreal
macular edema
triamcinolone
VEGF

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014