Over the past few years, the National Eye Institute (NEI), a division of the National Institutes of Health (NIH), has been conducting a secondary study to AREDS2 with ForeseeHome®.
The primary objective of the HOME Study was to determine whether home monitoring will lead to improved visual acuity at the time of wet AMD diagnosis compared with the standard of care.
Enrollment for the HOME Study began in July 2010 with participation from 44 retinal clinics nationwide. Enrollment ended in November 2012, and we successfully enrolled 1520 patients at risk of progression to wet AMD, an unprecedented number for a medical device study.
|Mean Visual Acuity at Baseline||20/25||20/25|
The study was a two-arm randomized clinical trial. Half of the participants were given the ForeseeHome, and patients in this group tested on their device regularly (on average, almost 5 times per week). The other half of the study participants received their clinic’s current standard of care for patients at risk of progression to wet AMD (no telemonitoring). This could include use of the Amsler grid or regular visits depending on each clinic’s standard practices.
On April 30, 2013, an independant safety and monitoring committee reviewed the study results and concluded that study eyes at risk of AMD progression presented to their study sites with significantly better vision when their neovascular AMD development was detected by the ForeseeHome device as compared to standard monitoring.
Therefore, the committee unanimously recommended early termination of the study as they were confident that the study has met its primary objective; namely, demonstrating that eyes at high risk of progression to neovascular AMD can be identified with better levels of vision when they are detected by use of the home monitoring device as compared to standard methods.
94% of ForeseHome patients that used the device as directed and converted to wet AMD kept their functional vision vs only 62% of patients using other detection methods.
Eyes that progressed to neovasuclar AMD were identified with significantly better levels of visual acuity in the device monitoring arm compared to standard care alone.