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ROTATE study shows letter gain in DME patients who switch anti-VEGF agents
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VIENNA — Six-month results of the Genentech-sponsored ROTATE trial showed benefits of switching to ranibizumab 0.3 mg in patients with diabetic macular edema after recent, frequent and long-term treatment with bevacizumab.
“Switching from Avastin to Lucentis in DME and other macular diseases is a common clinical scenario. However, prospective evaluations of DME switchers studies are usually not robust and usually have significant anti-VEGF washout periods,” Dennis Marcus, MD, said at the American Society of Retina Specialists meeting.
Dennis Marcus
The ROTATE study eliminated the washout period, requiring at least two bevacizumab (Avastin, Genentech) injections within 2 months of enrollment and six injections within 9 months. A total of 30 patients were divided into two groups, the first assigned to receive monthly treatment with ranibizumab (Lucentis, Genentech) for 12 months and the second to receive monthly treatment for 6 months followed by as-needed dosing.
“Results at 6 months show a robust response after 0.3 mg ranibizumab with an average gain of six letters and a thinning of 95 µm [in central subfield thickness] from baseline — a fairly significant improvement after switching,” Marcus said.
A gain of 10 or more letters was achieved in 31% of the patients, and 89% achieved greater than 10% thinning of central subfield thickness as seen on OCT.
Questions of whether this additional efficacy is specific to ranibizumab or secondary to tachyphylaxis, and whether regression to the mean is involved need to be clarified by larger studies, Marcus said.
However, the ROTATE study indicates that switching from bevacizumab to ranibizumab should be considered to improve results, he said. — by Michela Cimberle
Disclosure: Marcus reports he is a consultant to Genentech and Regeneron.