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| |  Bilateral Injections of Anti-VEGF Drugs for Treatment of Bilateral Macular Degeneration Appear Safe, Convenient: Presented at ARVO By Cameron Johnston FORT LAUDERDALE, Fla -- May 5, 2009 -- There is no particular increase in risk for patients with bilateral macular degeneration treated with bilateral injections of intravitreal anti-vascular endothelial growth factor inhibitors (VEGF), according to a study presented here at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting. In addition, there was a strong patient preference for the ease and convenience of having bilateral rather than unilateral injections, researchers said in a poster presentation on May 3. "Most ophthalmologists have a predilection against doing anything that will involve bilateral surgery" said KariAnne Galler, MD, University of Iowa, Iowa City, Iowa. For this reason, most doctors take a decidedly conservative approach toward many treatments, including the use of intravitreal anti-VEGF. However, Dr. Galler added that more than 85% of patients with bilateral macular degeneration who were treated with anti-VEGF therapies over a 26-month period, complained about the burden of having to come to the clinic twice each month for injections. Therefore it was felt that patients could be more accepting of bilateral injections done on the same day. Dr. Galler's study looked at the results from 102 patients who received bilateral injections and 102 who received unilateral injections of either bevacizumab or ranibizumab. Patients who received bilateral injections had a mean of 4.3 injections each (range, 1-13) while patients who received unilateral injections had a mean of 10.2 each (range, 2-28). Patients in the bilateral group received a total of 456 injections, while those in the unilateral group received a total of 1,017 injections (508 of bevacizumab, 509 of ranibizumab). The injections into each eye were done one immediately after the other, but they were treated as entirely separate procedures, Dr. Galler explained. Separate trays of sterile instruments were used for each eye, and the eyes did not receive drugs from the same manufacturer's lot. This would ensure that, if for any reason, there was contamination in 1 bottle, it would not be transmitted to both eyes.
The rates of adverse events were similar between the 2 groups. No cases of endophthalmitis or retinal detachment were seen in either group, and there was 1 case of nonfatal myocardial infarction in each group. There were 2 vascular deaths in the unilateral group and 1 vascular death in the bilateral group. There was 1 nonvascular death in each group. To put these data into perspective, Dr. Galler pointed out that the adverse event rate in the Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD (MARINA) was 4.6%, and adverse events for the current study was 1.98% for those receiving bilateral treatments and 0.98% for those receiving unilateral treatments. Overall, this study demonstrates that it is safe to offer bilateral injections of anti-VEGF drugs to patients who have active choroidal neovascularisation in both eyes, concluded Dr. Galler.
[Presentation title: Patient Preference and Safety of Bilateral Intravitreal Injection of Anti-VEGF Therapy. Abstract 247-A347]
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