OccuLogix to proceed with RHEO therapy trials

Toronto-The FDA is allowing OccuLogix Inc. to initiate studies of its RHEO blood filtration system to treat dry age-related macular degeneration after reviewing the Long-term Efficacy in AMD from Rheopheresis in North America (LEARN) protocols.

The LEARN open-label, multicenter trial will enroll up to 120 patients who have completed the "treatment arm" of its previous MIRA-1 phase III clinical trial. Each patient in the MIRA-1 trial received either eight RHEO therapy or eight placebo procedures over 10 weeks; the primary endpoint was the mean change in best spectacle-corrected visual acuity on the Early Treatment Diabetic Retinopathy Scale (ETDRS).

In the LEARN trial, subjects at up to 12 investigational sites will receive two or four RHEO therapy booster procedures, with results compared after 3, 6, 9, and 12 months.

Patient screening for inclusion in the two crossover studies is expected to begin in the second quarter.