Raising the Bar
Lowering the Burden
The clinical trials currently being conducted by Oraya Therapeutics include:
This study demonstrated that a patient population previously treated with anti-VEGF for up to three years experienced a 32% reduction of injections with substantially drier retinas with Oraya Therapy compared to the control group at twelve months following radiation treatment. Twenty-five percent of Oraya Therapy patients needed no further injections. Mean visual acuity of Oraya Therapy patients was maintained over one year. Patients who received Oraya Therapy exhibited better reduction of Central Subfield Thickness, Fovea Thickness and Total Macular Volume over one year compared to the control group. Furthermore, those patients with persistent significant macular edema, minimal fibrosis, and CNV size ≤4 mm had a 55% reduction in injections and nearly seven letters of vision superiority as compared to the control group. The one-year INTREPID results showed that this population had a 1 in 3 chance of needing no further injections, compared with no chance of zero injections using anti-VEGF alone.
INTREPID is intended to confirm the safety of low-voltage external beam radiotherapy using the IRay System at two dose levels for the treatment of CNV secondary to neovascular AMD, and to demonstrate that the IRay System is effective in sparing the number of Lucentis injections during the first 12 months. This is a randomized, double-masked, sham-controlled trial where subjects were assigned to one of four treatment groups: 16 Gy IRay radiotherapy + PRN Lucentis, sham 16 Gy radiotherapy + PRN Lucentis, 24 Gy radiotherapy + PRN Lucentis, and sham 24 Gy radiotherapy + PRN Lucentis. Patients at least 50 years of age, with CNV due to AMD diagnosed within the year preceding study enrollment, who had received at least 3 anti-VEGF injections, and who were without serious systemic illness such as diabetes, were included in the study. Patients received a Lucentis injection within 14 days prior to radiotherapy, and returned every 4 weeks thereafter to be assessed on the need for anti-VEGF retreatment. PRN Lucentis was administered on the basis of the following criteria: 1) ≥100 micron increase in central subfield thickness from best prior OCT; 2) or a >5 ETDRS letter decrease in vision since the last visit or the patient’s baseline vision, with disease activity; 3) or new/ increased macular hemorrhage shown on fundus photography. In addition to the primary outcome measure of reduction in the number of anti-VEGF injections, secondary measures include change in vision and change in CNV size, among others. The trial was fully enrolled in April 2011 with 226 patients, and the one-year data were reported at the 12th EURETINA Congress in Milan, Italy. This multi-national study includes sites in Austria, the Czech Republic, Germany, Italy and the United Kingdom.
IRay to Treat Polypoidal Choroidal Vasculopathy (PCV) Secondary to Age-Related Macular Degeneration (AMD)
This is a single-center, open-arm, interventional clinical pilot trial intended to evaluate the efficacy of Oraya Therapy at the 16 Gy dose in patients with Polypoidal Choroidal Vasculopathy (PCV) secondary to AMD, as determined by the change in the proportion of lesion activity and lesion size at 12 months. Patients received a Lucentis injection within 14 days prior to radiotherapy, and returned every 4 weeks thereafter to be assessed on the need for anti-VEGF retreatment. As-needed Lucentis was administered on the basis of the following criteria: 1) presence of any retinal fluid; 2) or a >5 ETDRS letter decrease in vision since the last visit or the patient’s baseline vision, with disease activity; 3) or new/increased macular hemorrhage shown on fundus photography. Ten patients were enrolled, and one year data were presented at the 2013 annual meeting of the Association for Research and Vision in Ophthalmology. The PCV aneurysmal bulge component was obliterated in all cases when included in the irradiation spot (9 out of 10 eyes), and there was only one recurrence at 12 months. Mean vision improved by 6 letters, and mean central retinal thickness declined by 45%. Patients required a mean of 2.9 additional injections. There were no observed local or systemic adverse events related to Oraya Therapy.
Safety & Tolerability of the IRay System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
The primary objective is to evaluate the safety and clinical feasibility of stereotactic radiotherapy with Oraya’s IRay System for the treatment of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD). One-year data have been published and presented, and further publications are pending. Patients will be followed for safety annually through year five.