NEWARK, Calif. — A clinical trial of noninvasive radiation therapy in wet age-related macular degeneration patients has met the primary endpoint of reduction of the number of anti-VEGF injections, Oraya Therapeutics announced in a news release.
Preliminary results of the sham-controlled, double-masked INTREPID study also showed no indication of radiation-related adverse events at the endpoint of the 1-year trial, according to the release.
Oraya CEO Jim Taylor said in the release that he expects the first treatments to begin within the next few months in nations that were part of the trial: Austria, Czech Republic, Germany, Italy and the United Kingdom.
The trial included 230 subjects who had received at least three anti-VEGF injections in the previous year, the release said. Within 2 weeks of injection, subjects were divided into one of three groups that received either a sham exposure or a radiation dose of 16 Gy or 24 Gy. Subjects were then followed and treated with Lucentis (ranibizumab, Genentech) as needed for 1 year.
Detailed results of the INTREPID study will be presented at the Euretina Congress in September in Milan, Italy.
Oraya Therapy is a one-time 20-minute procedure that uses low-energy, highly targeted X-rays for wet AMD treatment, the release said. The IRay system’s delivery approach, targeting algorithm, eye stabilization and tracking methods are proprietary. The device is CE marked in Europe and is limited to investigational use in the United States.