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news.Genentech has reported positive two-year results from a pivotal Phase III trial evaluating the efficacy and safety of Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME).
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The multicentre, randomized, double-masked, sham injection-controlled, 36-month trial involved 377 patients with DME, who were randomised to receive monthly injections of either 0.3mg Lucentis (n=125), 0.5mg Lucentis (n=125) or monthly sham injections.
The study results showed that DME patients who received Lucentis experienced rapid and sustained improvement in vision compared to those who received a placebo injection.
A significantly greater number of patients who received Lucentis were able to read at least 15 additional letters on the eye chart compared to baseline after 24 months, which was the primary endpoint.
A significant improvement was seen in average eye chart reading scores at 24 months and also as early as seven days.
Patients who Lucentis also had significantly decreased retinal swelling.