Intravitreal Bevacizumab and Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA)

NCT00997191 | Completed Phase 3 DMC

• 1 other identifier: 6826/2009
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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, the purpose of this study is to evaluate the effects of intravitreal bevacizumab and intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema.

Conditions

Diabetic Macular Edema

Keywords

Bevacizumab; Diabetes; Intravitreal; Macular edema; triamcinolone; VEGF

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual acuity

  One Year

Secondary Outcomes (3)

• Macular Mapping Test

  One Year

• Multifocal Electroretinogram

  One Year

• Central Macular Thickness

  One Year

Study Arms (3)

Laser Group

ACTIVE COMPARATOR

Focal / grid Laser photocoagulation in diabetic macular edema

Procedure: Laser photocoagulation

Triamcinolone group

EXPERIMENTAL

Intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema

Drug: Intravitreal triamcinolone

Bevacizumab group

EXPERIMENTAL

Intravitreal Bevacizumab associated to laser photocoagulation for diabetic macular edema

Drug: Intravitreal bevacizumab

Interventions

Laser photocoagulation PROCEDURE

Focal / grid photocoagulation for diabetic macular edema according to ETDRS guidelines

Laser Group

Intravitreal triamcinolone DRUG

Intravitreal preservative-free triamcinolone (4mg) associated to focal photocoagulation for diabetic macular edema on baseline; Re-treatment at weeks 20 and 40 if CMT\>275um

Also known as: Triancinolona (Ophthalmos)

Triamcinolone group

Intravitreal bevacizumab DRUG

Intravitreal bevacizumab (1.5mg) associated to focal photocoagulation for diabetic macular edema at baseline; Re-treatment at weeks 20 and 40 if CMT\>275um

Also known as: Avastin

Bevacizumab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically significant DME - by biomicroscopic evaluation with 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 20/40 or worse
• Central macular thickness greater than 275 µm on optical coherence tomography (OCT)

You may not qualify if:

• Glycosylated hemoglobin rate above 10%
• History of glaucoma or ocular hypertension
• 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
• Severe systemic disease
• Any condition affecting documentation or follow-up

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (15)

• Paccola L, Costa RA, Folgosa MS, Barbosa JC, Scott IU, Jorge R. Intravitreal triamcinolone versus bevacizumab for treatment of refractory diabetic macular oedema (IBEME study). Br J Ophthalmol. 2008 Jan;92(1):76-80. doi: 10.1136/bjo.2007.129122. Epub 2007 Oct 26.

  PMID: 17965109 BACKGROUND

• 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. doi: 10.1167/iovs.05-0297.

  PMID: 16186372 BACKGROUND

• Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.

  PMID: 2866759 BACKGROUND

• Garner A. Pathology of diabetic retinopathy. Br Med Bull. 1970 May;26(2):137-42. doi: 10.1093/oxfordjournals.bmb.a070765. No abstract available.

  PMID: 4192644 BACKGROUND

• Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.

  PMID: 2062512 BACKGROUND

• 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. doi: 10.1097/01.iae.0000246884.76018.63.

  PMID: 17151487 BACKGROUND

• Jonas JB, Kreissig I, Sofker A, Degenring RF. Intravitreal injection of triamcinolone for diffuse diabetic macular edema. Arch Ophthalmol. 2003 Jan;121(1):57-61.

  PMID: 12523885 BACKGROUND

• Lee CM, Olk RJ. Modified grid laser photocoagulation for diffuse diabetic macular edema. Long-term visual results. Ophthalmology. 1991 Oct;98(10):1594-602. doi: 10.1016/s0161-6420(91)32082-7.

  PMID: 1961650 BACKGROUND

• Kang SW, Sa HS, Cho HY, Kim JI. Macular grid photocoagulation after intravitreal triamcinolone acetonide for diffuse diabetic macular edema. Arch Ophthalmol. 2006 May;124(5):653-8. doi: 10.1001/archopht.124.5.653.

  PMID: 16682586 BACKGROUND

• Karacorlu M, Ozdemir H, Senturk F, Arf Karacorlu S, Uysal O. Macular function by multifocal electroretinogram in diabetic macular edema after intravitreal triamcinolone acetonide injection. Eur J Ophthalmol. 2008 Jul-Aug;18(4):601-8. doi: 10.1177/112067210801800417.

  PMID: 18609482 BACKGROUND

• Martidis A, Duker JS, Greenberg PB, Rogers AH, Puliafito CA, Reichel E, Baumal C. Intravitreal triamcinolone for refractory diabetic macular edema. Ophthalmology. 2002 May;109(5):920-7. doi: 10.1016/s0161-6420(02)00975-2.

  PMID: 11986098 BACKGROUND

• Kook D, Wolf A, Kreutzer T, Neubauer A, Strauss R, Ulbig M, Kampik A, Haritoglou C. Long-term effect of intravitreal bevacizumab (avastin) in patients with chronic diffuse diabetic macular edema. Retina. 2008 Oct;28(8):1053-60. doi: 10.1097/IAE.0b013e318176de48.

  PMID: 18779710 BACKGROUND

• Larsson J, Zhu M, Sutter F, Gillies MC. Relation between reduction of foveal thickness and visual acuity in diabetic macular edema treated with intravitreal triamcinolone. Am J Ophthalmol. 2005 May;139(5):802-6. doi: 10.1016/j.ajo.2004.12.054.

  PMID: 15860283 BACKGROUND

• Soheilian M, Ramezani A, Bijanzadeh B, Yaseri M, Ahmadieh H, Dehghan MH, Azarmina M, Moradian S, Tabatabaei H, Peyman GA. Intravitreal bevacizumab (avastin) injection alone or combined with triamcinolone versus macular photocoagulation as primary treatment of diabetic macular edema. Retina. 2007 Nov-Dec;27(9):1187-95. doi: 10.1097/IAE.0b013e31815ec261.

  PMID: 18046223 BACKGROUND

• Vujosevic S, Pilotto E, Bottega E, Benetti E, Cavarzeran F, Midena E. Retinal fixation impairment in diabetic macular edema. Retina. 2008 Nov-Dec;28(10):1443-50. doi: 10.1097/IAE.0b013e318183571e.

  PMID: 18997608 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Macular Edema

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Maria L Paccola, MD

  HC FMRP - USP

  STUDY CHAIR

• André M V Messias, PhD

  HCFMRP - USP

  STUDY CHAIR

• Bianka Y N Y Katayama, MD

  HC FMRP - USP

  STUDY DIRECTOR

• Rodrigo Jorge, PhD

  HC FMRP - USP

  PRINCIPAL INVESTIGATOR

• Rogério A Costa, PhD

  HC FMRP - USP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 19, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 4, 2013

Record last verified: 2013-02

Locations

BR (1)