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 oedema.
The study results showed that diabetic macular oedema patients who were treated with 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 an 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 even as early as seven days.
Patients who received Lucentis also had significantly decreased retinal swelling.
The multicentre, randomised, double-masked, sham injection-controlled, 36-month trial involved 377 patients with diabetic macular oedema, who were randomised to receive monthly injections of either 0.3mg Lucentis, 0.5mg Lucentis or monthly sham injections.
Diabetic macular oedema is an eye condition characterised by swelling of the retina, which can occur in patients with type 1 or type 2 diabetes and lead to blurred vision, severe vision loss and blindness.
