QLT Inc. today announced it has completed enrolling 160 patients in the Company's Phase II
RADICAL trial to determine if combination therapy with Visudyne reduces retreatment rates compared with an anti-VEGF antibody while maintaining similar vision outcomes and an acceptable safety profile.
"The completion of enrollment in the RADICAL trial signifies that we are one step closer to our goal of having the use of Visudyne followed by Lucentis, with or without an anti-inflammatory agent, potentially added to the product's label," said Bob Butchofsky, President and Chief Executive Officer.
The RADICAL trial is a Phase II, multicenter, randomized, single-masked study comparing reduced-fluence Visudyne-Lucentis combination therapies and Lucentis monotherapy in subjects with choroidal neovascularization secondary to age-related macular degeneration. Patients are randomized to receive one of four treatments: Reduced fluence Visudyne followed by Lucentis, Reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy, Very low-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy, or Lucentis monotherapy. The duration of the trial is 24 months.
Source:QLThttp://www.qltinc.com/Qltinc/pages/pagespressdetail.cfm?PressID=332&InternetCenterID=13&Type=Home&InternetPageID=31