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

This study is ongoing, but not recruiting participants.

Sponsored by: University of Sao Paulo
Information provided by: University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00468351
  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 I

Genetics Home Reference related topics:   X-linked juvenile retinoschisis   

MedlinePlus related topics:   Edema   

ChemIDplus related topics:   Bevacizumab    Triamcinolone acetonide    Triamcinolone    Triamcinolone diacetate    Triamcinolone hexacetonide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema

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

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

Locations
Brazil, São Paulo
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:
Arevalo JF, Fromow-Guerra J, Quiroz-Mercado H, Sanchez JG, Wu L, Maia M, Berrocal MH, Solis-Vivanco A, Farah ME; Pan-American Collaborative Retina Study Group. Primary intravitreal bevacizumab (Avastin) for diabetic macular edema: results from the Pan-American Collaborative Retina Study Group at 6-month follow-up. Ophthalmology. 2007 Apr;114(4):743-50.
 
Bonini-Filho MA, Jorge R, Barbosa JC, Calucci D, Cardillo JA, Costa RA. Intravitreal injection versus sub-Tenon's infusion of triamcinolone acetonide for refractory diabetic macular edema: a randomized clinical trial. Invest Ophthalmol Vis Sci. 2005 Oct;46(10):3845-9.
 
Costa RA, Jorge R, Calucci D, Melo LA Jr, Cardillo JA, Scott IU. Intravitreal bevacizumab (avastin) for central and hemicentral retinal vein occlusions: IBeVO study. Retina. 2007 Feb;27(2):141-9.
 
Jorge R, Costa RA, Calucci D, Cintra LP, Scott IU. Intravitreal bevacizumab (Avastin) for persistent new vessels in diabetic retinopathy (IBEPE study). Retina. 2006 Nov-Dec;26(9):1006-13.
 
Costa RA, Jorge R, Calucci D, Cardillo JA, Melo LA Jr, Scott IU. Intravitreal bevacizumab for choroidal neovascularization caused by AMD (IBeNA Study): results of a phase 1 dose-escalation study. Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4569-78.
 
Audren F, Lecleire-Collet A, Erginay A, Haouchine B, Benosman R, Bergmann JF, Gaudric A, Massin P. Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg. Am J Ophthalmol. 2006 Nov;142(5):794-99. Epub 2006 Sep 15.
 
Chun DW, Heier JS, Topping TM, Duker JS, Bankert JM. A pilot study of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema. Ophthalmology. 2006 Oct;113(10):1706-12.
 
Cunningham ET Jr, Adamis AP, Altaweel M, Aiello LP, Bressler NM, D'Amico DJ, Goldbaum M, Guyer DR, Katz B, Patel M, Schwartz SD; Macugen Diabetic Retinopathy Study Group. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology. 2005 Oct;112(10):1747-57.
 
Haritoglou C, Kook D, Neubauer A, Wolf A, Priglinger S, Strauss R, Gandorfer A, Ulbig M, Kampik A. Intravitreal bevacizumab (Avastin) therapy for persistent diffuse diabetic macular edema. Retina. 2006 Nov-Dec;26(9):999-1005.
 

Study ID Numbers:   154342005
First Received:   May 1, 2007
Last Updated:   May 1, 2007
ClinicalTrials.gov Identifier:   NCT00468351
Health Authority:   Brazil: National Committee of Ethics in Research

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

Study placed in the following topic categories:
Eye Diseases
Diabetes Mellitus
Edema
Macular Degeneration
Retinal Degeneration
Triamcinolone diacetate
Bevacizumab
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Triamcinolone
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Glucocorticoids
Hormones
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 15, 2008




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