Oraya Therapeutics has completed enrollment of its INTREPID (IRay plus anti-VEGF Treatment for Patients with Wet Age-related Macular Degeneration) clinical trial in Europe.
The sham-controlled, double-masked trial evaluates the effectiveness and safety of Oraya's radiation therapy in conjunction with standard-of-care anti-VEGF injections for the treatment of wet age-related macular degeneration (AMD).
Oraya's IRay stereotactic radiotherapy system uses externally delivered robotically controlled low-energy x-rays. The treatment is a one-time nonsurgical procedure that may significantly reduce or eliminate the need for subsequent anti-VEGF injections, while maintaining or improving vision outcomes in treated patients.
Enrollment was capped at 226 subjects. One-third of patients received a sham exposure, with the remainder receiving a radiation dose of either 16 or 24 Gy. The 24 sites of the trial include locations in Austria, Czech Republic, Germany, Italy, and the U.K.
Oraya said it has plans to conduct a larger study in the U.K. and elsewhere beginning later this year.
