Phase 3 N=10 Randomized Other

Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

Diabetic Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT01661946 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Maximum Concentration (Cmax) of Anti-VEGF Antibody — 25.22; 9.56 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bevacizumab (Drug); Ranibizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Queen's University
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Concentration (Cmax) of Anti-VEGF Antibody	25.22; 9.56	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01661946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.