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OpenTrials
Completed

NCT Number: NCT01661946

Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

Currently, two similar medications are available for injection into the eye to treat a variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab (Avastin). They both have a similar mechanism of action and work equally well, however only ranibizumab was designed for use in the eye. It is significantly more expensive per injection than bevacizumab (by a factor of roughly 40x).

In published studies trends have been noted towards an increased rate of systemic side effects such as heart attacks and strokes. This is presumably due to absorption of the drug(s) from the eye into the bloodstream, however this has never been shown before. The purpose of the investigators study was to compare the bloodstream levels of bevacizumab and ranibizumab at various time points after injection into the eye. This required the creation of a sophisticated assay to measure blood levels of the drugs.

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Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

About this study

see above

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients in whom anti-vascular endothelial growth factor (VEGF) therapy is indicated for the treatment of diabetic macular edema
  • able to return for extra clinic visits according to study schedule

Exclusion criteria

  • active malignancy
  • previous retinal laser treatment
  • previous anti-VEGF therapy
  • previous vitrectomy

Treatment and study plan

Bevacizumab

Drug

Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.

Other names: Avastin

ranibizumab

Drug

Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use

Other names: Lucentis

Primary outcomes

  1. Maximum Concentration (Cmax) of Anti-VEGF Antibody

    Time frame: 1 month

    The serum concentrations of anti-VEGF antibody (bevacizumab or ranibizumab) will be measured pre-injection as well as at various time points after injection (1 day, 1 week, 2 weeks, 1 month). These time points are selected based on previously completed animal studies. The Cmax will be compared between bevacizumab and ranibizumab.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Systemic Absorption of Bevacizumab and Ranibizumab in Humans Treated for Diabetic Macular Edema

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 10, 2012
Registry last updated
May 31, 2019

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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