NIH Study Finds Patients at High-Risk for Developing Neovascular Age-Related Macular Degeneration Benefit from ForeseeHome Monitoring for Early Detection of CNV
The results of the Home Monitoring of the Eye (HOME) study, conducted in Age-Related Eye Disease Study 2 (AREDS2) clinical centers, executed by the EMMES Corporation and sponsored by Notal Vision Ltd. Tel Aviv, Israel, have been accepted for publication in Ophthalmology. The results show that participants at high risk for developing choroidal neovascularization (CNV), the neovascular or wet phase of age-related macular degeneration (AMD), using the ForeseeHome monitoring device strategy had significantly better preservation of their visual acuity at the time of CNV detection than the control group of participants who were only using standard care methods to self monitor their AMD for progression. The study’s Data Safety and Monitoring Committee recommended early termination of the study on April 2, 2013 based on superior vision outcomes among the participants randomly assigned to use the home device.
The AREDS2 HOME Study was a collaborative effort led by the National Eye Institute to evaluate the performance of a home monitoring device plus standard care compared to standard care monitoring alone for the detection of AMD progression to the neovascular phase. Standard care methods may include periodic monocular self checks of vision clarity, blind spots and distortion, which may include use of an Amsler grid. As treatments to manage the neovascular phase of AMD have improved, the importance of early detection of this event has increased in an effort to optimize outcomes following treatment of neovascular AMD. Approximately 8 million individuals in the United States, age 50 and older, are estimated to have intermediate (large drusen) or advanced AMD in one eye, placing them at high risk of progression to AMD, ranging from 25 to 50% over a five-year period.
Results of the HOME Study and Implications for AMD Management At the time of CNV detection, 87% of eyes in the ForeseeHome device arm maintained visual acuity of 20/40 or better compared to 62% in the standard care alone arm. Median acuity among device users at the time of CNV diagnosis was 20/32. Among participants who used the device at the recommended minimum frequency (twice per week) to monitor their AMD for progression, 94% of eyes that progressed to CNV maintained 20/40 or better visual acuity. When CNV was detected, participants in the ForeseeHome device arm lost fewer letters on visual acuity testing (median loss of 4 letters) from entry levels of vision at the start of the study compared to those in the standard care alone arm (median loss of 9 letters). Use of the ForeseeHome device resulted in an increase in the proportion of CNV events first identified at home, meaning in between routine ophthalmic office visits to assess detection of disease progression. Among individuals using standard care methods for monitoring, only 55% of those that progressed noted symptoms at home that led them to present for examination; whereas 80% of the participants in the device monitoring group returned sooner than a scheduled visit because a change was noted by the device or by self-monitoring. This was associated with a greater degree of vision preservation at CNV diagnosis among individuals who returned promptly for changes, as the median visual acuity loss at CNV detection was 3.0 letters for those in the device arm compared with 11.5 letters for those in the standard care group. The average annual rate of false alerts among the device users, reported as the annual false positive rate, was 0.24 alerts/year, which may be extrapolated to one false alert on average every 4.2 years for each ForeseeHome user.
“Persons 60 years of age or older should undergo dilated eye examinations to determine their risk of developing advanced AMD, especially CNV,” said Jeffrey S. Heier, M.D., Director of the Vitreoretinal Service and the Director of Retina Research at Ophthalmic Consultants of Boston and one of the principal investigators of the HOME Study. “In contrast to current home monitoring strategies, those with intermediate AMD (bilateral large drusen) or advanced AMD in 1 eye are likely to benefit from home monitoring with the ForeseeHome device to detect the development of CNV at an earlier stage with better preservation of their visual acuity to maximize visual acuity results after intravitreal therapy with anti-VEGF agents.” About the HOME Study The HOME Study was a controlled, randomized clinical trial that was part of AREDS2. The study was conducted in 44 clinical centers across the U.S., enrolling 1,520 participants at high risk for developing CNV. The objective of the HOME Study was to determine whether monitoring with the ForeseeHome device plus standard care results in earlier detection of CNV compared to standard care alone. Standard care included instructions to the patient on self-monitoring for CNV. Better visual acuity at the time of CNV detection is both a reflection of earlier CNV detection as well as a favorable predictor for visual function outcomes following the management of CNV with intraocular anti-angiogenic medications.