Study objective and design1
The Home Monitoring of the Eye (HOME) study was a collaborative effort from investigators of the AREDS2 study who conducted a secondary study that evaluated whether home monitoring using ForeseeHome detected CNV at better levels of vision compared with standard care methods. The HOME study involved 44 centers and enrolled 1520 participants with AREDS Category 3 and 4 dry AMD, who were at risk for the progression to CNV, into the clinical trial. The study was a long-term (3 year), Phase 3, unmasked clinical trial that participants were randomized 1:1 into either the device group (ForeseeHome users) or standard care group. Standard care was defined by the investigator and may have included use of the Amsler grid.
The cohorts in the ForeseeHome arm were defined by the frequency with which participants used the device. The overall group represented the ITT cohort, with this group further categorized to PP1 and PP2 cohorts.