Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

Sponsor
Queen's University
Study ID
NCT01661946
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 10, 2012
Start date
Aug 31, 2012
Status verified
Feb 2019
Primary completion
Jul 31, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Ranibizumab
    intravitreal injection of 0.5mg ranibizumab in usual fashion
  • Active Comparator: Bevacizumab
    intravitreal injection of 1.25mg bevacizumab in usual fashion

Primary Outcome Measure

Maximum Concentration (Cmax) of Anti-VEGF Antibody [ Time Frame: 1 month ]

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