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Additionally, the company is conducting two studies in patients with wet AMD. The first trial, which is a monotherapy study in newly diagnosed patients not previously treated for the disease, is intended to demonstrate Perceiva's biological activity in wet AMD. MacuSight has completed enrollment of 20 patients in this single-site, open-label, parallel study. Patients enrolled in this re-dose trial are administered Perceiva by either subconjunctival injection or the traditional, more invasive intravitreal injection at baseline, again at two months and a final time at four months. The primary endpoints for the trial are changes in visual acuity and retinal thickness measured at six months.
MacuSight's second wet AMD study, known as the EMERALD trial, is designed to evaluate the therapeutic potential of Perceiva in combination with Lucentis® in patients with wet AMD. The company has completed enrollment of 62 previously treated wet AMD patients at 28 investigational sites. Patients in this randomized, dose-ranging, placebo-controlled study are being administered Perceiva via subconjunctival injection, along with Lucentis, at baseline and again at two months. Roche's Lucentis is currently approved by the United States Food and Drug Administration for the treatment of wet AMD. The primary endpoints of this combination trial are changes in visual acuity and retinal thickness measured at four months.
"In conducting these two complementary studies in wet AMD, MacuSight is taking a comprehensive approach to assessing the therapeutic potential of Perceiva in this disease," stated Pravin U. Dugel, M.D., managing partner, Retinal Consultants of Arizona, Phoenix, AZ, clinical instructor, vitreoretinal diseases and surgery, department of ophthalmology, University of Arizona, a
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