NeoVista announced that it will be completing the study of Epi-Rad90 Ophthalmic System by April 2011.
Intraocular epiretinal radiation device is intended for the treatment of the wet form of Age-Related Macular Degeneration (AMD). The concept behind this device is, an intraocular device that delivers and directs radiation to the choroidal vascular bed of the retina. Local delivery of radiation will permit selective treatment of the neovascular lesion while minimizing neurosensory degeneration due to secondary radiation exposure. Ionizing radiation causes changes in the structure of a small fraction of molecules in each exposed cell. Because proliferating cells are usually more sensitive to ionizing radiation than are non-proliferating cells, ionizing radiation is commonly used to retard/stop abnormal proliferation of cells, i.e. cancerous tumors.
The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD). The Epi-Rad90 Ophthalmic System treats neovascularization of retinal tissue by means of a focal, directional delivery of radiation to the target tissues in the retina. Using standard vitreoretinal surgical techniques, the sealed radiation source is placed temporarily over the retinal lesion by means of a handheld medical device.
The 450 patient, phase III study is currently recruiting participants. The official title of the study is “A Randomized, Prospective, Active Controlled, Study of the Epi-Rad90 Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration”.