Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

Phase 3

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Ranibizumab; Drug: Bevacizumab

• Registration Number: NCT01661946
• Lead Sponsor: Queen's University

Brief 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

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-10
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2019-02
• Results First Submitted: 2019-02-26
• Results First Submitted QC: 2019-02-26
• Last Update Submitted: 2019-02-26
• Results First Posted: 2019-05-31
• Last Update Posted: 2019-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab	intravitreal injection of 0.5mg ranibizumab in usual fashion
Bevacizumab	Bevacizumab	intravitreal injection of 1.25mg bevacizumab in usual fashion

Primary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) of Anti-VEGF Antibody	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.

Trial Locations

Locations (1)

Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada