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J. J. Nassaralla, Jr., B. A. Nassaralla; Incidence of Adverse Events Associated With the Use of Intravitreal Bevacizumab X Ranibizumab - Comparative Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):513.
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To identify adverse events associated with the use of intravitreal bevacizumab (B) or ranibizumab (R) in patients with exudative Age-Related Macular Degeneration (AMD).
Retrospective review of a consecutive series of 100 eyes of 100 patients who received three intravitreal B or R 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 B or R, whether or not considered related to the medicinal product.
Of the 50 eyes injected B, 2 eyes had significant inflammation (1+ cell and flare), 1 eye had significant punctate keratitis, 1 eye had vitreous hemorrhage, 2 eyes accelerated formation of cataract, 50 eyes conjunctival hemorrhage, 1 eye endophthalmitis and 11 eyes developed pain during the follow up period. Of the 50 eyes injected R, 1 eye had significant inflammation (1+ cell and flare), no eyes had significant punctate keratitis, 1 eye had vitreous hemorrhage, 2 eyes accelerated formation of cataract, 50 eyes conjunctival hemorrhage, 1 eye endophthalmitis and 7 eyes developed pain during the follow up period. No statistical difference was seen between both groups at any time-point
B and R were well tolerated and had a low rate of ocular adverse events in this study.
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