The ForeseeHome AMD Monitor is the first FDA cleared home based telemonitoring system for patients with age-related macular degeneration (AMD). It is indicated for patients diagnosed with the dry form of AMD who are at risk of developing the sight threatening wet form of AMD.  The ForeseeHome utilizes a proprietary technology platform called Preferential Hyperacuity Perimetry.  Patients complete a short test on their ForeseeHome system from the comfort of their home.  These test results are automatically transmitted to the Notal Vision Data Monitoring Center through an imbedded cellular or phone modem and are available to the prescribing doctor and patient through a secure website.  If there is a statistically significant change in test results, Notal Vision will promptly alert the doctor and the patient so that a comprehensive eye exam can be scheduled. Due to the rapid progression of vision loss associated with wet AMD, ForeseeHome testing is recommended daily.  Early detection and early treatment of wet AMD are the best chance to prevent vision loss and preserve quality of life.

FORESEEHOME STUDY ENDED EARLY DUE TO POSITIVE RESULTS

 

The HOME Study- 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 the ForeseeHome®. We are pleased to announce that the Data and Safety Monitoring Committee (DSMC) for the study has ended the study early due to positive results.

 

Study Design-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.

   HOME Study Participant Characteristics:

 

 

Characteristic

ForeseeHome

N=763

Standard Care

N=757

Male

42%

40%

Female

58%

60%

Mean Age

72.6

72.3

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, 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.

 

Study Ended Early- On April 30, 2013, the DSMC 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 DSMC unanimously recommended early termination of the study as they are 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.

 

Study Results- Notal vision is hoping to have results of the HOME Study published and available to the public in late November 2013.  You can follow them on Facebook (www.facebook.com/foreseehome) or check their website (www.foreseehome.com) later this year to learn more.

 

 

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