This article is more than 5 years old. Information may no longer be current.
Oraya Therapeutics begins enrollment for radiation therapy trial in wet AMD
Click Here to Manage Email Alerts
NEWARK, Calif. — Oraya Therapeutics has begun enrollment for the first masked and sham-controlled clinical trial to assess the safety and efficacy of radiation therapy for treating patients with wet age-related macular degeneration, the company announced in a press release.
The study, which will evaluate the effect of adjunct radiation therapy on the frequency of anti-VEGF injections and visual outcomes, will enroll a minimum of 150 patients with wet AMD at seven European sites. Approximately two-thirds of these patients will receive radiation dosing of either 16 Gy or 24 Gy delivered via the Oraya's IRay system; the remainder of the patients will receive sham exposure. All patients will receive standard anti-VEGF therapy.
Oraya's noninvasive, low-energy, stereotactic IRay platform showed an "excellent safety profile" over 1-year of follow-up in a phase 1 study that enrolled more than 60 patients with wet AMD, the release said. The IRay system employs Oraya's I-Guide vacuum-assisted contact lens interface to maintain eye stability and track eye movement during treatment.
The procedure requires a topical anesthetic and is 15 to 20 minutes in duration, according to the release.
Oraya plans to evaluate trial endpoints at 1 year after the completion of radiation therapy.