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Data Analysis Shows Promise of Epiretinal Brachytherapy as NeoVista
Progresses with Phase III CABERNET Study
PALM BEACH, Fla., March 28 /PRNewswire/ -- NeoVista, Inc. released today to the eye community updated results from a one-year feasibility study of the company's novel epiretinal brachytherapy for the wet form of age-related macular degeneration (AMD) at the 31st Annual Macula Society Meeting in Palm Beach, Florida. The promising data from the study, which was initiated by NeoVista to test the efficacy and safety of their novel therapy when used in conjunction with Avastin(R) (bevacizumab), showed a marked improvement in mean visual acuity.
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.
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 partic
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