The US Food and Drug Administration has approved the expansion of US medical device company, Neovista's CABERNET trial (Marketletter December 3, 2007).
The number of sites participating in the Phase III trial of the company's radiation treatment for the wet form of age-related macular degeneration, will expand from the current 10 sites to 30.
CABERNET is a multicenter, randomized, controlled study that will enroll 450 subjects at clinical centers worldwide. The study will evaluate the safety and efficacy of NeoVista's epiretinal brachytherapy, delivered with the standard Lucentis (ranibizumab) treatment for AMD versus Lucentis alone.
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