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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2009

Last Updated Date

February 28, 2013

Start Date ^ICMJE

October 2009

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00997191 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetic Macular Edema

Intervention ^ICMJE

Procedure: Laser photocoagulation
Focal / grid photocoagulation for diabetic macular edema according to ETDRS guidelines
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)
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

Study Arm (s)

Active Comparator: Laser Group
Focal / grid Laser photocoagulation in diabetic macular edema

Intervention: Procedure: Laser photocoagulation
Experimental: Triamcinolone group
Intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema

Intervention: Drug: Intravitreal triamcinolone
Experimental: Bevacizumab group
Intravitreal Bevacizumab associated to laser photocoagulation for diabetic macular edema

Intervention: Drug: Intravitreal bevacizumab

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Brazil

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00997191

Other Study ID Numbers ^ICMJE

6826/2009

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Rodrigo Jorge, University of Sao Paulo

Study Sponsor ^ICMJE

University of Sao Paulo

Collaborators ^ICMJE

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators ^ICMJE

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

Information Provided By

University of Sao Paulo

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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