NCT01661946

Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

see above

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.
DRUG	Ranibizumab	Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2012-08-10
• Last updated: 2019-05-31
• Results posted: 2019-05-31

Locations

1 site across 1 country: Canada