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Completed

NCT Number: NCT02118831

Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

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.

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Key information

Conditions

Age-Related Macular Degeneration Cardiovascular Diseases Diabetic Macular Edema Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample collection

Biological

Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.

aflibercept

Drug

an intravitreal injection of Aflibercept administered three times on a monthly basis.

Other names: Eylea

Bevacizumab

Drug

an intravitreal injection of Bevacizumab administered three times on a monthly basis.

Other names: Avastin

ranibizumab

Drug

an intravitreal injection of Ranibizumab administered three times on a monthly basis.

Other names: Lucentis

Primary outcomes

  1. Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses

    Time frame: 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 outcomes

  1. Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

California Retina Consultants

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2014
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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