Safety of an Intravitreal Injection of Bevacizumab (Avastin): Results of a Multicenter Trial

Abstract

Purpose: : To report the systemic and ocular complications of an intravitreal injection of bevacizumab (Avastin).

Methods: : Open label, uncontrolled clinical study of eyes injected with either 1.25 mg or 2.5 mg intravitreal bevacizumab for a variety of retinal disorders including diabetic macular edema, macular edema secondary to branch and central retinal vein occlusions, proliferative diabetic retinopathy, neovascular glaucoma and choroidal neovascularization secondary to age–related macular degeneration, myopia and idiopathic causes. Patients underwent a complete ocular examination at baseline, weekly during the first month and then every month. Monitored systemic conditions included myocardial infarction, stroke, systemic hypertension, thromboembolic diseases and death. Bevacizumab was stored under refrigeration in two different ways: 1– A single vial of 100 mg /4 mL was re–utilized as needed; and 2– The contents of the vial were aliquoted out into single use injections under sterile conditions.

Results: : 372 intravitreal injections of bevacizumab in 361 eyes were reported from five centers in five countries. No cases of death, myocardial infarction, stroke, thromboembolic diseases, or colonic perforation were reported. No cases of endophthalmitis, uveitis, retinal detachment or cataract were reported. One patient with a prior history of primary open angle glaucoma developed an elevation in intraocular pressure, which was easily treated with additional topical medication.

Conclusions: : An intravitreal injection of either 1.25 mg or 2.5 mg of bevacizumab appears to be safe and well tolerated during the first three months. Monitoring of the adverse side effects in these patients will continue.

Keywords: drug toxicity/drug effects • choroid: neovascularization • retinal neovascularization