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.
INTREPID confirmed 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 demonstrated that the IRay System is effective in sparing the number of Lucentis injections. This was 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 included change in vision and change in CNV size, among others. This multi-national study included sites in Austria, the Czech Republic, Germany, Italy and the United Kingdom. The trial was fully enrolled in April 2011 with 226 patients.
At year one, the INTREPID trial met its primary endpoint, demonstrating that the Oraya therapy significantly reduced the number of anti-VEGF injections. Two year results demonstrated that overall Oraya therapy reduced the number of injections by one quarter. 15% of subjects required no anti-VEGF injections in the two years following treatment and 45% required 3 injections or fewer. Patients with abnormal macular fluid and a lesion size with a greatest linear dimension of ≤4 mm had the best response to treatment. For eyes with these characteristics, there was a significant 45% reduction in anti-VEGF treatments. Microvascular changes were seen in a small percentage of subjects, but were generally outside the foveal zone and rarely affected vision.
This was 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. Primary outcome measure was the regression of polyps as assessed by ICG angiography. Secondary outcome measures included best corrected visual acuity (BCVA) and central foveal thickness changes measured on OCT. Twelve patients were enrolled. Mean vision improved by 6 letters, and mean central retinal thickness declined by 45%. 10 of 12 eyes showed complete regression of polyps at month 12. The same 10 eyes showed BCVA improvement. Mean vision improved by 6 letters, and mean central retinal thickness declined by 45%. 10 Patients required a mean of 2.9 additional injections. There were no observed local or systemic adverse events related to Oraya Therapy.