Intrepid Study Demonstrates 2-Year Safety, Efficacy of Oraya Therapy
Two-year results of the Intrepid study of Oraya Therapy stereotactic radiotherapy for the treatment of wet age-related macular degeneration (AMD) demonstrated a favorable safety profile and the therapy’s ability to reduce the frequency of anti-VEGF injections, according to a company news release. The results were also presented by Timothy L. Jackson, MD, at the Euretina Congress in Hamburg.1
The Intrepid study is the first to evaluate the effectiveness and safety of Oraya Therapy with the IRay system in conjunction with as-needed anti-VEGF injections and the only sham-controlled, double-masked trial to assess stereotactic radiotherapy for wet AMD, according to the company. A total of 21 sites in 5 European countries participated in the trial, with a total enrollment of 230 patients; 212 patients were followed through the 2-year visit. The study met its primary efficacy endpoints, showing that Oraya Therapy significantly reduced the need for anti-VEGF injections in patients with wet AMD and demonstrated a favorable safety profile.
Over 2 years, the cohort of non-naïve wet AMD patients received a 25% mean reduction in anti-VEGF injections. Patients identified in the first year as ideal response candidates maintained a 45% mean reduction in anti-VEGF injections through 2 years, with superior vision to the untreated group; these candidates were identified through post hoc analysis as patients with significant fluid in the retina at baseline and a lesion size of 4 mm or less in greatest linear dimension, which corresponds to the diameter of IRay x-ray beam spot centered on the fovea.
The overall safety profile was positive, with 1% of treated patients showing evidence of microvascular abnormalities due to radiation.
“A treatment that offers the prospect of fewer injections will be welcomed by clinicians and patients alike,” Dr. Jackson said in the news release. “Importantly, if we select the right patients, vision appears to be better than with anti-VEGF monotherapy. The safety at 2 years is also encouraging, in that most microvascular changes were located away from the fovea, and so did not have an impact on vision.”
- Jackson TL. Stereotactic radiotherapy for the treatment of neovascular age-related macular degeneration: year results of the INTREPID trial. Paper presented at: the 13th Euretina Congress; September 26, 2013; Hamburg, Germany.