Oraya Initiates Sham- Controlled Study of Radiation Therapy for Wet AMD

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Oraya Therapeutics, Inc. (Newark, CA), began enrollment for what the company called the first sham-controlled study to demonstrate the efficacy and safety of radiation therapy for the treatment of wet age-related macular degeneration (AMD).

According to a company news release, the trial will be conducted at seven sites in Europe and will include at least 150 patients receiving standard of care anti-vascular endothelial growth factor (VEGF) drug therapy. Approximately one-third of patients will receive sham exposure, and the remaining patients will receive radiation dosing of either 16 or 24 Gy. The trial is designed to measure the effect of the radiation adjunct—delivered with Oraya’s IRay system, a noninvasive, low-energy stereotactic X-ray platform—on vision outcomes and on the frequency of anti-VEGF injections . Patients will be evaluated at 1 year.

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