Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study) - Full Text View

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

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