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With ForeseeHome, 94% of patients who progressed to
wet AMD retained functional vision (≥20/40) vs only 62% of patients using standard detection methods alone1

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

VIEW A CASE STUDY

Including ForeseeHome reduced vision loss at wet AMD diagnosis by 6 letters compared with standard care alone1

> 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

Lesion sizes were significantly smaller at wet AMD diagnosis with ForeseeHome vs standard care alone1,3-5

Lesion Chart

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.

  • Lesions were approximately 3-fold smaller at CNV diagnosis with ForeseeHome vs standard care alone in the HOME study1

The HOME Study was terminated early for efficacy1

  • The independent Data Safety and Monitoring Committee recommended that the HOME Study be terminated early because ForeseeHome demonstrated significantly fewer letters of vision loss at incident CNV resulting in early detection of CNV compared to standard care alone

ForeseeHome is not appropriate for some patients1,6

  • ForeseeHome is not recommended for patients with any disorder that may prohibit them from steadily using a mouse or with impaired cognitive function (ie, Alzheimer’s disease or Parkinson’s disease)
  • Up to 1 in 5 patients may not be able to establish a baseline due to pre-existing visual field defects or nonophthalmic conditions
  • Your patients will have 2 attempts to establish a baseline. If they do not establish a baseline, other tools for monitoring their vision should be recommended

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.

HOW TO PRESCRIBEORDER FORM

Study Design

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.

Study cohorts1

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.

Study Design Table

Need for Early Detection

Early detection is critical to maintaining functional vision

  • Early diagnosis is essential for preserving functional vision7
  • Lesions at the onset of CNV grow more quickly, resulting in more rapid vision loss than later stage lesions7
  • On average, patients with 20/40 visual acuity or better at diagnosis of wet AMD maintained that level of vision at 1 and 2 years following treatment7
  • Absolute vision is better preserved when anti-VEGF therapy is initiated while CNV lesions are small and VA has not yet deteriorated

*Based on an analysis of CATT.
CATT=Comparison of AMD Treatments Trials; VEGF=vascular endothelial growth factor.

Deficiencies of the Amsler Grid

For the vast majority of patients, some vision loss is irreversible by the time

wet AMD is detected with standard methods

*Range of 13%-41% from clinical trials that include CATT and IVAN and real-world experience.
  • Only up to 41% of newly diagnosed patients with CNV are detected early with good functional vision

Deficiencies of the Amsler grid

Because wet AMD progresses rapidly, frequent monitoring is critical

  • The Amsler Grid alone is not effective, detecting early wet AMD (≥20/40) in as little as 9% of patients2
  • Wet AMD may be present for 6-12 months before detection and treatment7

    When distortion is noticed on the Amsler grid, vision loss has already progressed.

    ForeseeHome utilizes technology that overcomes many limitations of the Amsler grid.

Amsler Table

HOW IT WORKS

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FDA Indication for Use

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.