Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

California Retina Consultants56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 4 months

Secondary Outcomes

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).

Time frame: baseline and month 4