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news.Genentech, a member of the Roche, said RISE (FVF4170g) study evaluating monthly Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint.
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RISE is a multicenter, randomized, double-masked, sham injection-controlled, 36-month Phase III study designed to assess the safety and efficacy profile of Lucentis in 377 patients with DME.
The primary endpoint compared the proportion of Lucentis and sham-treated patients who gained at least 15 letters in BCVA at month 24, relative to baseline.
RISE showed that a significantly higher percentage of patients receiving monthly Lucentis achieved an improvement in vision (BCVA) of at least 15 letters on the eye chart at 24 months, compared to those in a control group, who received a placebo (sham) injection, Genetech said.
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor which was first approved by the FDA for the treatment of neovascular (wet) age-related macular degeneration (AMD) in June 2006.
Lucentis was also approved by the US Food and Drug Administration for macular edema following retinal vein occlusion (RVO) on 22 June 2010.