wet AMD earlier
with ForeseeHome as part of
a home detection program
The HOME Study used the ETDRS chart to measure the number of letters for visual acuity. The Snellen equivalent for visual acuity is presented here.
Study design: An unmasked, controlled, randomized clinical trial of 1520 participants 53 to 90 years of age at high risk of CNV. The study compared home monitoring with ForeseeHome plus standard care vs standard care alone to determine if the addition of the home monitoring device improved visual acuity at the time of CNV detection.1
As few as 17.5% of patients have a baseline VA of ≥20/40 (Snellen equivalent) at treatment initiation based on real-world data2
Patients’ vision decreased by only 3 letters in the ForeseeHome arm vs 9 letters when wet AMD was detected at the time of a regularly scheduled visit1
> Office visits triggered by using ForeseeHome as part of a home monitoring plan were 16 times more likely to catch new cases of wet AMD compared with routine scheduled office visits1
1 disc area=2.54 mm2.
Study design: An unmasked, controlled, randomized clinical trial of 1520 participants 53 to 90 years of age at high risk of CNV. The study compared home monitoring with ForeseeHome plus standard care vs standard care alone to determine if the addition of the home monitoring device improved visual acuity at the time of CNV detection.
AMD=age-related macular degeneration; CNV=choroidal neovascularization; ETDRS=Early Treatment Diabetic Retinopathy Study; ITT=intent to treat cohort; PP1=per protocol 1 cohort; PP2=per protocol 2 cohort(tested 2 or more times per week); VA=visual acuity.
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.
*Based on an analysis of CATT.
CATT=Comparison of AMD Treatments Trials; VEGF=vascular endothelial growth factor.
wet AMD is detected with standard methods
Because wet AMD progresses rapidly, frequent monitoring is critical
When distortion is noticed on the Amsler grid, vision loss has already progressed.
ForeseeHome utilizes technology that overcomes many limitations of the Amsler grid.
The ForeseeHome is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration, as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to choroidal neovascularization (CNV). It is intended to be used at home for patients with stable fixation.
The ForeseeHome AMD Monitoring Program is only available by physician order and is intended to be used as an addition to regular eye exams.
The technical component of the ForeseeHome AMD Monitoring Program is covered by Medicare, subject to its coverage requirements for the test, to assess patients with dry AMD who are at risk of developing wet AMD. Please refer to your local Medicare Administrative Contractor (MAC) for which the ordering physician resides concerning coverage availability for the physician professional services component of the test.