RHEO goes to trial
OccuLogix has received Investigational Device Exemption (IDE) clearance from the FDA to begin a pivotal Phase III study of the RHEO procedure to treat dry age-related macular degeneration (AMD).
OccuLogix has received Investigational Device Exemption (IDE) clearance from the FDA to begin a pivotal Phase III study of the RHEO procedure to treat dry age-related macular degeneration (AMD).
The study, a multicentre, prospective, randomized, double-masked, sham-controlled trial, will evaluate the safety and efficacy of the RHEO procedure in patients with intermediate to late stage dry AMD. Each patient will receive either eight RHEO treatments or eight sham procedures over an eight-week period. The primary endpoint of the study will be the mean change from baseline to 12 months in best corrected visual acuity (BCVA).
The RHEO procedure is a method of apheresis, whereby a patient's blood is drawn outside the body and specific compounds are removed before the blood is returned to the body.
The RHEO-AMD trial is expected to support OccuLogix's application for FDA market approval.
