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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Rodrigo Jorge, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00997191
First received: October 15, 2009
Last updated: February 28, 2013
Last verified: February 2013
  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, 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 Intervention Phase
Diabetic Macular Edema
Procedure: Laser photocoagulation
Drug: Intravitreal triamcinolone
Drug: Intravitreal bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab and Intravitreal Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA)

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Best Corrected Visual acuity [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Macular Mapping Test [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  • Multifocal Electroretinogram [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  • Central Macular Thickness [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: October 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00997191

Locations
Brazil
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
Investigators
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

Publications:

Responsible Party: Rodrigo Jorge, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00997191     History of Changes
Other Study ID Numbers: 6826/2009
Study First Received: October 15, 2009
Last Updated: February 28, 2013
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 August 28, 2014