Interim INTREPID trial safety results trend toward minimal radiation-induced changes
NEW ORLEANS – Interim safety data for the INTREPID trial thus far yield a 15% rate of radiation-induced microvascular changes in patients at 3 years, according to a presenter.
“In this previously treated patient population, the INTREPID trial met its primary superiority outcome with a 33% reduction at 1 year in the number of Lucentis injections, and this effect persisted out to 24 months with a 25% reduction,” Darius M. Moshfeghi, MD, said at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting.
Darius M. Moshfeghi
In the INTREPID study, patients with an ongoing need for treatment who were previously treated with at least three anti-VEGF injections in the year before starting the study, received an injection of Lucentis (ranibizumab, Genentech) at baseline and then were randomized to receive either 16 or 24 Gy or sham radiation. Patients were followed monthly with time-based optical coherence tomography. Primary outcome was the reduction in the number of ranibizumab injections.
Image analysis on 55 patients carried out to year 3 shows eight new cases of microvascular changes, with five attributed to radiation treatment with 16 Gy and three attributed to normal disease activity, Moshfeghi said.
“To put this into perspective, at 24 months, the entire cohort demonstrated a 25% reduction in the number of injections and a large subgroup demonstrated a 45% reduction , with only 15% of microvascular changes occurring that were related to radiation and not appearing to impact visual acuity,” he said.
Disclosure: Moshfeghi is a consultant for and holds equity in Oraya Therapeutics.