Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

Phase 1

Completed

• Conditions: Diabetic Macular Edema; Retinal Vein Occlusion; Age-related Macular Degeneration
• Interventions: Biological: Blood Sample Collection; Drug: Bevacizumab; Drug: Ranibizumab; Drug: Aflibercept

• Registration Number: NCT02118831
• Lead Sponsor: California Retina Consultants

Brief Summary

Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2014-02
• Study Completion: 2014-04
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Results First Submitted: 2016-01-27
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-13
• Last Update Submitted: 2016-04-13
• Results First Posted: 2016-05-19
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Ability to provide written informed consent for participation in this study
• 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 unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bevacizumab Blood Sample Collection	Bevacizumab	Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Ranibizumab Blood Sample Collection	Blood Sample Collection	Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Ranibizumab Blood Sample Collection	Ranibizumab	Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Aflibercept Blood Sample Collection	Blood Sample Collection	Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Aflibercept Blood Sample Collection	Aflibercept	Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Bevacizumab Blood Sample Collection	Blood Sample Collection	Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.

Primary Outcome Measures

Name	Time	Method
Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses	Up to 4 months	Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.

Secondary Outcome Measures

Name	Time	Method
Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)	baseline and month 4	Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment).