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
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Tracking Information | ||||||||||||||||
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First Submitted Date ICMJE | October 15, 2009 | |||||||||||||||
First Posted Date ICMJE | October 19, 2009 | |||||||||||||||
Last Update Posted Date | March 4, 2013 | |||||||||||||||
Study Start Date ICMJE | October 2009 | |||||||||||||||
Actual 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 ] | |||||||||||||||
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 |
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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. |
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Study Type ICMJE | Interventional | |||||||||||||||
Study Phase | Phase 3 | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Diabetic Macular Edema | |||||||||||||||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||
Actual Enrollment ICMJE |
12 | |||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||||||||
Actual Study Completion Date | November 2011 | |||||||||||||||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||||||||||||||
Accepts Healthy Volunteers | No | |||||||||||||||
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 | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement | 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 |
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PRS Account | 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 |