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

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ClinicalTrials.gov Identifier: NCT00997191
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : March 4, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Procedure: Laser photocoagulation Drug: Intravitreal triamcinolone Drug: Intravitreal bevacizumab Phase 3

Detailed Description:

Macular edema is a leading cause of decreased visual acuity in patients with diabetic retinopathy1,2.

Laser photocoagulation is the standard of care treatment for diabetic macular edema, based on ETDRS and recent clinical trials findings3,4. However, because visual acuity improvement post-laser is observed infrequently, and because of the frequent recurrence or persistence of DME (refractory DME) after appropriate laser treatment, particularly in eyes presenting with angiographically diffuse macular edema5-9, there is a need for alternative treatments for the management of DME. In addition, for some patients with significant cataract, precise visualization of posterior pole structures may not be possible, so that pharmacological therapy with intravitreal agents may be preferable over laser treatment.

Recent studies have shown promising results of pharmacological therapies for Diabetic macular edema. Triamcinolone has shown similar results when compared to ranibizumab and deferred focal/grid LASER in pseudophakic eyes (DRCRnet, prompt versus deferred). Ranibizumab associated with deferred LASER or as monotherapy has also shown promising results (RISE and RIDE). However, there are several concerns regarding long-term intravitreal injections therapies that include economic feasibility for the public health system, risk of endophthalmitis and patient acceptability. For these reasons, the present study decided to check associations between LASER and drug therapy, in an attempt to improve focal/grid laser outcomes with reduced number of intravitreal injections.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab and Intravitreal Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA)
Study Start Date : October 2009
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Laser Group
Focal / grid Laser photocoagulation in diabetic macular edema
Procedure: Laser photocoagulation
Focal / grid photocoagulation for diabetic macular edema according to ETDRS guidelines
Experimental: Triamcinolone group
Intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema
Drug: Intravitreal triamcinolone
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
Other Name: Triancinolona (Ophthalmos)
Experimental: Bevacizumab group
Intravitreal Bevacizumab associated to laser photocoagulation for diabetic macular edema
Drug: Intravitreal bevacizumab
Intravitreal bevacizumab (1.5mg) associated to focal photocoagulation for diabetic macular edema at baseline; Re-treatment at weeks 20 and 40 if CMT>275um
Other Name: Avastin

Outcome Measures

Primary Outcome Measures :
  1. Best Corrected Visual acuity [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. Macular Mapping Test [ Time Frame: One Year ]
  2. Multifocal Electroretinogram [ Time Frame: One Year ]
  3. Central Macular Thickness [ Time Frame: One Year ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Contacts and Locations

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): NCT00997191

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Chair: Maria L Paccola, MD HC FMRP - USP
Study Chair: André M V Messias, PhD HCFMRP - USP
Study Director: Bianka Y N Y Katayama, MD HC FMRP - USP
Principal Investigator: Rodrigo Jorge, PhD HC FMRP - USP
Study Chair: Rogério A Costa, PhD HC FMRP - USP
More Information


Responsible Party: Rodrigo Jorge, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00997191     History of Changes
Other Study ID Numbers: 6826/2009
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: February 2013

Keywords provided by Rodrigo Jorge, University of Sao Paulo:
Macular edema

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