Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

Study Overview
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Brief Summary
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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.

Official Title
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Systemic Pharmacokinetics Following Intravitreal Injections of Ranibizumab, Bevacizumab or Aflibercept in Patients With Neovascular Age-related Macular Degeneration

Conditions
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Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion

Intervention / Treatment
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* Biological: Blood Sample Collection
* Drug: Aflibercept
* Drug: Bevacizumab
* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aflibercept Blood Sample Collection<br>Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy. | Biological: Blood Sample Collection<br>* Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.<br>Drug: Aflibercept<br>* an intravitreal injection of Aflibercept administered three times on a monthly basis.<br>* Other names: Eylea;|
| Active Comparator: Bevacizumab Blood Sample Collection<br>Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy. | Biological: Blood Sample Collection<br>* Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.<br>Drug: Bevacizumab<br>* an intravitreal injection of Bevacizumab administered three times on a monthly basis.<br>* Other names: Avastin;|
| Active Comparator: Ranibizumab Blood Sample Collection<br>Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy. | Biological: Blood Sample Collection<br>* Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.<br>Drug: Ranibizumab<br>* an intravitreal injection of Ranibizumab administered three times on a monthly basis.<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment) | 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). | baseline and month 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular degeneration, diabetic macular edema, vein occlusion, vascular endothelial growth factor