NeoVista®, Inc. Completes Enrollment in Pivotal CABERNET™ Study
November 2, 2009
Endpoint Analysis Submission to FDA Upon Completion of One-Year Follow-up
NeoVista, Inc. announced the completion of enrollment in its global 450-patient randomized controlled study of their revolutionary epimacular brachytherapy procedure for the treatment of neovascular age-related macular degeneration (AMD). The Company will now begin the mandated one-year data follow-up before submitting the final clinical module of its Pre-Market Approval (PMA) submission to the FDA.
“It’s exciting to reach this long anticipated milestone in the CABERNET Study,” said John N. Hendrick, President and CEO of NeoVista. “Neovascular AMD affects hundreds of thousands of patients globally. It is our hope that upon one-year follow-up, the data will support FDA approval in a most timely manner so that retinal surgeons, patients, and heath care systems in the US and around the world will have a cost effective option available for treating this dreadful disease in the immediate future.”
The largest study of its kind to date, the multi-center CABERNET (CNV Secondary AMD Treated with BEta RadiatioN Epiretinal Therapy) Study assigned patients into one of two arms: a control arm where patients were administered regular Lucentis® injections and a one time surgical arm, where patients were administered a dose of strontium-90 beta radiation via a short surgical procedure, followed by concomitant injections of Lucentis when needed. The primary efficacy endpoint for the CABERNET Study is based on one-year follow-up of the surgical arm cohort when compared to the control group.
“The CABERNET Study has brought together multi-disciplinary clinical teams aligned around the mission of addressing the serious problem of neovascular AMD,” said Pravin U Dugel, Managing Partner, Retinal Consultants of Arizona, Phoenix, Arizona and principal investigator for the CABERNET Study. “I look forward to the final results of this ambitious clinical trial. More than any other recent trial, this clinical trial has the potential of improving the quality of life and the overall treatment of patients with neovascular AMD. It could potentially have a significant impact on the practice patterns and economics of retinal physicians as well as global health care systems.”
Source: Company News Release
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