CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10 enrolled
Drug / intervention
Bevacizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01661946
NCT01661946Phase 3Completed

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

Queen's University·interventional·Posted Aug 10, 2012·Updated May 31, 2019

In Brief

A Phase 3 clinical trial evaluating Bevacizumab and Ranibizumab for Diabetic Macular Edema. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2012
Enrollment StartAug 1, 2012
Primary CompletionJul 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.9 years ago

Interventions

Bevacizumabdrug

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

Ranibizumabdrug

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