Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF
NCT ID: NCT02118831
Last Updated: 2016-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2012-03-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Aflibercept Blood Sample Collection
Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Blood Sample Collection
Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
Aflibercept
an intravitreal injection of Aflibercept administered three times on a monthly basis.
Bevacizumab Blood Sample Collection
Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Blood Sample Collection
Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
Bevacizumab
an intravitreal injection of Bevacizumab administered three times on a monthly basis.
Ranibizumab Blood Sample Collection
Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Blood Sample Collection
Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
Ranibizumab
an intravitreal injection of Ranibizumab administered three times on a monthly basis.
Interventions
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Blood Sample Collection
Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
Aflibercept
an intravitreal injection of Aflibercept administered three times on a monthly basis.
Bevacizumab
an intravitreal injection of Bevacizumab administered three times on a monthly basis.
Ranibizumab
an intravitreal injection of Ranibizumab administered three times on a monthly basis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection
Exclusion Criteria
* Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year
* Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion
* Subjects with history of vitrectomy
ALL
No
Sponsors
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California Retina Consultants
OTHER
Responsible Party
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Principal Investigators
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Robert L Avery, MD
Role: PRINCIPAL_INVESTIGATOR
California Retina Consultants
Melvin D Rabena, BS
Role: STUDY_DIRECTOR
California Retina Consultants
References
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Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41. doi: 10.1136/bjophthalmol-2014-305252. Epub 2014 Jul 7.
Other Identifiers
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ML28032
Identifier Type: -
Identifier Source: org_study_id
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