Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye
NCT ID: NCT01661946
Last Updated: 2019-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
10 participants
INTERVENTIONAL
2012-08-31
2013-08-31
Brief Summary
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In published studies trends have been noted towards an increased rate of systemic side effects such as heart attacks and strokes. This is presumably due to absorption of the drug(s) from the eye into the bloodstream, however this has never been shown before. The purpose of the investigators study was to compare the bloodstream levels of bevacizumab and ranibizumab at various time points after injection into the eye. This required the creation of a sophisticated assay to measure blood levels of the drugs.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Ranibizumab
intravitreal injection of 0.5mg ranibizumab in usual fashion
Ranibizumab
Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use
Bevacizumab
intravitreal injection of 1.25mg bevacizumab in usual fashion
Bevacizumab
Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.
Interventions
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Bevacizumab
Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.
Ranibizumab
Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* able to return for extra clinic visits according to study schedule
Exclusion Criteria
* previous retinal laser treatment
* previous anti-VEGF therapy
* previous vitrectomy
18 Years
ALL
No
Sponsors
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The Physicians' Services Incorporated Foundation
OTHER
Queen's University
OTHER
Responsible Party
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Dr. Sanjay Sharma
Principal Investigator
Principal Investigators
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Sanjay Sharma, MD MBA MSc FRCSC
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Queen's University
Locations
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Hotel Dieu Hospital
Kingston, Ontario, Canada
Countries
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Other Identifiers
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QueensU
Identifier Type: -
Identifier Source: org_study_id
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