NCT02118831

Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: California Retina Consultants · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Age-related Macular Degeneration
• Diabetic Macular Edema
• Retinal Vein Occlusion

Interventions

Type	Name	Description
BIOLOGICAL	Blood Sample Collection	Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
DRUG	Aflibercept	an intravitreal injection of Aflibercept administered three times on a monthly basis.
DRUG	Bevacizumab	an intravitreal injection of Bevacizumab administered three times on a monthly basis.
DRUG	Ranibizumab	an intravitreal injection of Ranibizumab administered three times on a monthly basis.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-02-01
• Completion: 2014-04-01
• First posted: 2014-04-21
• Last updated: 2016-05-19
• Results posted: 2016-05-19