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Genentech reports positive 2-year results for ranibizumab in diabetic macular edema
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Two-year preliminary results from the phase 3 RISE study showed that a significantly higher percentage of patients with diabetic macular edema receiving monthly ranibizumab experienced visual gains of 15 letters or more compared with patients who received sham injection, according to a press release from Genentech.
The 36-month, randomized, double-masked, sham injection-controlled RISE study is evaluating the safety and efficacy profile of ranibizumab (Lucentis, Genentech) among 377 patients with diabetic macular edema. In the study, 125 patients were randomly assigned to receive monthly injections of 0.3 mg of ranibizumab, while 125 patients received 0.5 mg of ranibizumab and 127 patients received monthly sham injections. Both dose concentrations of ranibizumab were compared against sham injection, according to the release.
Rescue laser treatment was provided for all patients at 3 months on an as-needed basis, the release said.
With 24 months of the 36-month study now completed, patients in the control group will be eligible to receive monthly injections of 0.5 mg ranibizumab for the remainder of the study.
Genentech plans to present top-line results from the RISE study at the Macula Society Meeting in March.
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