Jeffrey S. Heier, MD, a retinal specialist, partner at Ophthalmic Consultants of Boston and a consultant for NeoVista, presented the one-year data obtained from trial participants (mean age, 72 years) who enrolled from June 2006 to April 2007 at two centers in Brazil and one in Mexico.
In the ongoing nonrandomized, multicenter feasibility study, 34 subjects with predominantly classic, minimally classic, or occult (with no classic) choroidal neovascularization (CNV) received a single 24 Gy treatment of NeoVista’s epiretinal brachytherapy in combination with two injections of Avastin®, one dose prior to or at the time of radiation delivery and another one month later, depending on which arm of the trial the patient was enrolled in.
After 12 months of follow-up on 33 of the trial participants, subjects had experienced a mean improvement in visual acuity of 10 letters using the Early Treatment Diabetic Retinopathy Study (ETDRS) test; 94 percent of patients lost fewer than 15 letters, 39 percent gained 15 or more letters, and 12 percent gained 30 or more letters. 76 percent of the patients in the study did not require additional injections of Avastin® throughout the year.
Most adverse events were related to the vitrectomy procedure (retinal tear, retinal detachment, subretinal hemorrhage, and vitreous hemorrhage). No events related to radiation toxicity have been reported to date.
In contrast to other forms of radiation therapy for wet AMD, NeoVista’s approach delivers the peak dose of energy directly to the lesion without damaging the normal retinal vasculature or other structures within the eye such as the lens and the optic nerve. Utilizing strontium 90, the focused energy is delivered to a target area up to 3 mm in depth and up to 5.4 mm in diameter. Importantly for patients, the systemic exposure to radiation is minimal, as the effective dose to the entire body from NeoVista’s epiretinal device is less than that from a typical chest x-ray.
NeoVista Inc is further exploring the safety and efficacy of the novel Epiretinal brachytherapy concomitantly with the FDA-approved antiangiogenic therapy Lucentis® (ranibizumab) versus Lucentis® alone in the CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy) trial. CABERNET is a multicenter, randomized, controlled Phase III study that will enroll 450 subjects at clinical centers worldwide.
For further information on trial sites and eligibility criteria, go to www.cabernetstudy.com.
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