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| |  Few Side Effects After 60 Days With Bevacizumab Therapy for Age-Related Macular Degeneration: Presented at ARVO By Ed Susman FORT LAUDERDALE, Fla -- May 4, 2009 -- Most ocular adverse effects associated with bevacizumab therapy for exudative age-related macular degeneration (AMD) resolve within 2 months following therapy, researchers reported at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting. "Short-term results suggest that intravitreal bevacizumab is well tolerated and had a low rate of ocular adverse effects," said Jaoa J. Nassaralla, MD, Goiânia Eye Institute, Goiânia, Brazil, on May 3 in a poster presentation. "The results suggest that further studies are required to determine the long-term safety and efficacy of this treatment." Dr. Nassaralla and colleagues conducted a retrospective chart review of a consecutive series of 780 eyes of 642 patients who received 2 intravitreal bevacizumab injections to treat exudative AMD. While conjunctival haemorrhage was noted in 658 eyes after 1 month of therapy, in 2 months the condition had cleared in all the eyes and had not returned after 3 months. The only lingering adverse side effects that were apparent after 2 months involved 1 individual who complained of pain, 2 cases of vitreous haemorrhage, 2 cataracts, and 1 retinal pigment epithelial tear. The 2 cases of cataracts and 1 vitreous haemorrhage remained after 3 months, but there was no worsening of the conditions, Dr. Nassaralla said. All patients included in the study had at least 3 months of follow up. The chart reviews were scrutinised to evaluate the incidence of adverse events in the second and third month after the initial injection, focusing on the standard ocular and systemic adverse events, routinely utilised in clinical trials. In addition to the ocular adverse events, the researchers were also checking for any unfavourable or unintended sign, symptom, or disease temporally associated with the use of bevacizumab, whether or not considered related to the medicinal product. Aside from conjunctival haemorrhage, adverse events during the first 30 days included 11 cases of pain, 8 reports of ocular irritation, 8 cases of significant irritation, 3 cases of punctuate keratitis, 2 vitreous haemorrhages, 1 case of endophthalmitis, and 1 case of retinal pigment endothelial tear. Dr. Nassaralla said the patients did not report any cases of choroidal abnormalities: ocular hypertension, retinal detachment, systemic events, soreness or traumatic cataract. Cataracts only appeared after 60 days of treatment, he said.
[Presentation title: Incidence of Adverse Events Associated With the Use of Intravitreal Bevacizumab (Avastin) in Eyes With Exudative Age Related Macular Degeneration - 780 Cases. Abstract 955]
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