Abstract
Purpose: :
To identify adverse events associated with the use of intravitreal Avastin ® (Roche, Rio de Janeiro, Brazil) in patients with exudative Age-Related Macular Degeneration (AMD).
Methods: :
Retrospective review of a consecutive series of 780 eyes of 642 patients who received two intravitreal Avastin to treat exudative AMD. All patients had at least three month of follow up. We performed a chart review of these patients to evaluate the incidence of adverse events in the second and third month after the initial injection. Standard ocular and systemic adverse events, routinely utilized in clinical trials, were evaluated. The ocular adverse events included accelerated formation of cataract, ocular hypertension (>30mm) for more than one week, clinically significant inflammation, significant retinal or choroidal vascular abnormalities not seen at baseline, and adverse events associated with the injection procedure (conjunctival injection, conjunctival hemorrhage, pain, soreness, irritation, vitreous hemorrhage, traumatic cataract, retinal detachment, endophthalmitis). We also looked for systemic adverse events, including any unfavorable or unintended sign, symptom, or disease temporally associated with the use of Avastin, whether or not considered related to the medicinal product.
Results: :
Of the 780 eyes injected, eight eyes had significant inflammation (1+ cell and flare), three eye had significant punctate keratitis, one eye had vitreous hemorrhage, two eyes accelerated formation of cataract, 658 eyes conjunctival hemorrhage, one eye endophthalmitis and eleven eyes developed pain during the follow up period.
Conclusions: :
Avastin was well tolerated and had a low rate of ocular adverse events in this study.
Clinical Trial: :
www.clinicaltrials.gov NCT00556348
Keywords: age-related macular degeneration • retinal neovascularization • retina