The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide

Abstract

Aim: Off-label intravitreal injections of bevacizumab (Avastin) have been given for the treatment of neovascular and exudative ocular diseases since May 2005. Since then, the use of intravitreal bevacizumab has spread worldwide, but the drug-related adverse events associated with its use have been reported only in a few retrospective reviews. The International Intravitreal Bevacizumab Safety Survey was initiated to gather timely information regarding adverse events from doctors around the world via the internet. Methods: An internet-based survey was designed to identify adverse events associated with intravitreal bevacizumab treatment. The survey web address was disseminated to the international vitreoretinal community via email. Rates of adverse events were calculated from participant responses. Results: 70 centres from 12 countries reported on 7113 injections given to 5228 patients. Doctor-reported adverse events included corneal abrasion, lens injury, endophthalmitis, retinal detachment, inflammation or uveitis, cataract progression, acute vision loss, central retinal artery occlusion, subretinal haemorrhage, retinal pigment epithelium tears, blood pressure elevation, transient ischaemic attack, cerebrovascular accident and death. None of the adverse event rates exceeded 0.21%. Conclusion: Intravitreal bevacizumab is being used globally for ocular diseases. Self-reporting of adverse events after intravitreal bevacizumab injections did not show an increased rate of potential drug-related ocular or systemic events. These short-term results suggest that intravitreal bevacizumab seems to be safe.

Comparative Study of Intravitreal Bevacizumab (Avastin) versus Ranibizumab (Lucentis) in the Treatment of Neovascular Age-Related Macular Degeneration

“…These observations are in line with the reported literature [4,5,6,7,8,9,10,11,12,13,14,15,16,17,18]. In our data, out of 187 ranibizumab injections there were 2 events (1.1%) of transiently elevated IOP of more than 30 mm Hg, which required administration of IOP-lowering drops.…”

“…There were no reported cases of endophthalmitis in the PIER study [10]. According to the internet-based survey of Fung et al[ 15], the incidence of endophthalmitis after using intravitreal injections of bevacizumab was 0.01%. Cleary et al[ 12] also reported 1 case of endophthalmitis during the median follow-up of 5 months of 112 patients treated with bevacizumab.…”

“…According to the internet-based survey of Fung et al[ 15], which was self-reported, the most common potential procedure-related adverse events related to bevacizumab injection included corneal abrasion (0.15%), lens injury (0.01%), retinal detachment (0.04%), mild surface discomfort (0.14%), subconjunctival hemorrhage (0.03%), episodes of inflammation (0.14%), cataract progression (0.01%), acute vision loss (0.07%), central retinal artery occlusion (0.01%), new or progressive subretinal hemorrhages (0.06%) and tears of the retinal pigment epithelium (0.06%). The incidence of ocular complications after repeated intravitreal injections of either 1.25 or 2.5 mg of bevacizumab, reported by Wu et al [17], included bacterial endophthalmitis (0.16%), tractional retinal detachment (0.16%), uveitis (0.09%), rhegmatogenous retinal detachment (0.02%) and vitreous hemorrhage (0.02%).…”

A systematic review on the effect of bevacizumab in exudative age-related macular degeneration

“…Adverse events reported were corneal abrasion, lens injury, endophthalmitis, retinal detachment, inflammation or uveitis, cataract progression, acute vision loss, central retinal artery occlusion, subretinal haemorrhage, retinal pigment epithelium tears, blood-pressure elevation, transient ischaemic attack, cerebrovascular accident and death. None of the adverse event rates exceeded 0.21% [22]. These results are also confirmed by a 12-month follow-up study of 1,265 consecutive patients with various diagnoses, including exudative AMD, who received 4,303 intravitreal injections of bevacizumab [46].…”

Efficacy of Photodynamic Therapy in the Management of Occult Choroidal Neovascularization Associated with Serous Pigment Epithelium Detachment

“…This effect on the already damaged RPE, due to the age-related macular degeneration, may further deteriorate the junctions between the RPE cells and predispose to the development of an RPE tear. However, as this complication may as well occur during the natural course of CNV associated with PED or even after intravitreal injection of antiangiogenic drugs, other factors such as the contraction of the neovascular membrane or the pressure of the subpigment epithelium fluid may also contribute to the development of this complication [16,17,18]. …”