Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Retina Consultants
• Treatments: Aflibercept; Bevacizumab; Polystyrene sulfonic acid; Ranibizumab

Criteria

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