Oraya Therapeutics Inc. completed enrollment of its INTREPID (I-Ray plus aNti-VEGF TREatment for Patients wIth Wet AMD) clinical trial April 15 in Europe, with 226 subjects.
Newark, CA-Oraya Therapeutics Inc. completed enrollment for its INTREPID (I-Ray plus aNti-VEGF TREatment for Patients wIth Wet AMD) clinical trial April 15 in Europe, with 226 subjects.
The sham-controlled, double-masked trial is designed to evaluate the effectiveness and safety of radiation therapy in conjunction with anti-vascular endothelial growth factor (VEGF) injections for the treatment of wet age-related macular degeneration (AMD). One-third of the subjects received a sham exposure, with the remainder receiving a radiation dose of either 16 or 24 Gy. The multinational study includes sites in Austria, Czech Republic, Germany, Italy, and the United Kingdom.
Oraya’s proprietary stereotactic radiotherapy system (IRay) is designed to deliver a highly localized dose of x-ray radiation to the macula using a proprietary positioning system, targeting algorithm, and special contact lens for eye stabilization and tracking. According to Oraya, the treatment is a one-time non-surgical procedure that may significantly reduce or eliminate the need for subsequent anti-VEGF injections while maintaining or improving vision outcomes in treated patients.
The company’s stereotactic radiotherapy system has CE Mark approval, which means the company is permitted to market it in the European Economic Area. The device is limited to investigational use in the United States.
One-year efficacy results of the INTREPID study will be available in the second quarter of 2012.