Home Monitor for Macular Degeneration Preserves Vision

Caroline Helwick

November 27, 2013

NEW ORLEANS — For patients with age-related macular degeneration, home monitoring for disease activity leads to early identification of choroidal neovascularization, which can help preserve visual acuity at the time of progression, according to the AREDS2 study.

Results from the trial, known as the Age-Related Eye Disease Study 2: Home Monitoring of the Eye, were presented here at the American Academy of Ophthalmology (AAO) 2013 Annual Meeting.

Early detection of neovascular age-related macular degeneration has become especially important in the era of anti-VEGF therapy, noted investigator Susan Bressler, MD, from the Johns Hopkins University School of Medicine in Baltimore. Anti-VEGF therapy helps preserve visual acuity, and 1-year outcomes are better when treatment is initiated while baseline visual acuity is still high.

Unfortunately, studies performed from 2000 to 2010 have indicated that early detection is uncommon, she explained.

In the randomized clinical trial, AREDS2 investigators evaluated the performance of Notal Vision's ForeseeHome monitoring device.

They compared home-monitoring plus standard monitoring, which consists of periodic monocular self checks of vision clarity, blind spots, and distortion, with standard monitoring alone.

The device is a prescription-based comprehensive telemonitoring and data management system that allows visual field testing to be conducted in a patient's home. The device uses a monitoring center to alert the physician when a patient experiences a significant visual field change between office visits. Patients can then receive immediate follow-up and treatment.

This represents an increase of 43% to 51% in the likelihood of maintaining 20/40 vision.

The study involved 1520 patients with at least 1 large drusen, visual acuity of at least 20/60, and no advanced macular degeneration. Investigators evaluated changes in visual acuity from baseline in the 81 patients who progressed to choroidal neovascularization.

An intent-to-treat analysis looked at patients who were randomized to the device, but who may or may not have used it. The per protocol analysis looked at patients who followed the minimal practice recommendation of monitoring at least twice a week.

Patients using the device had better preservation of visual acuity at the time choroidal neovascularization was detected. In fact, 87% of patients had vision of 20/40 or better, Dr. Bressler reported.

In the intent-to-treat analysis, median letter change from baseline was lower in the device group than in the control group (–4.0 vs –9.0; P = .021). The same pattern was seen in the per protocol analysis (–3.0 vs –9.0; P = .005).

For secondary outcomes, visual acuity of at least 20/40 was maintained more often in the device group than in the control group in the intent-to-treat analysis (87% vs 62%; P = .014). The same pattern was seen in the per protocol analysis (94% vs 62%; P = .003).

"This represents an increase of 43% to 51% in the likelihood of maintaining 20/40 vision," Dr. Bressler noted.

Fewer eyes had a loss of at least 15 letters from baseline in the device group than in the control group in the intent-to-treat analysis (12% vs 23%; P = .146). The same pattern was seen in the per protocol analysis (23% vs 6%; P = .045). This represents a 50% to 75% reduction in the likelihood of losing 3 lines of vision, she added.

More Events Identified

More choroidal neovascularization events were identified at home in the device group than in the control group (80% vs 55%). This was associated with greater vision preservation at choroidal neovascularization diagnosis. Median visual acuity loss was 3.0 letters with the device and 11.5 letters with standard care.

There were 237 false alerts during 987 monitoring-years, which amounted to an annual false-positive rate of 24%. "This can be extrapolated to an average of 1 false-positive device alert per 4.2 monitoring-years for every device user," Dr. Bressler explained.

"There is no question that home monitoring is the future," said Pravin Dugel, MD, from Retinal Consultants of Arizona in Phoenix and clinical associate professor at the Doheny Eye Institute at the University of Southern California, Los Angeles.

"The fact is that patients simply cannot come in to the office on a monthly basis. We also want to have personalized medicine, where patients are able to feel that their home is part of the doctor's office," Dr. Dugel told Medscape Medical News.

The ForeseeHome device is one of several that are now available, and the others might be even more efficient, he pointed out.

"The plus side of the ForeseeHome device is that it has been well tested and, in motivated patients, it has been shown to work," he said. "The downside is that the results go through a third-party call center, and not directly to the physician's office."

Dr. Dugel noted that the Digisight phone app, which is free to download, can perform tests other than visual acuity and can directly link to the physician's office. He reported that he has been an advisor to both device manufacturers.

William Rich III, MD, AAO medical director of health policy and chair of the registry measure development work group, said that home-monitoring of many chronic diseases is only going to increase, and will be one way to "help us with work force issues."

This is being done with many forms of chronic illness, such as hypertension, where physicians monitor patients remotely and adjust their medications without the need for frequent office visits. The need and opportunity to remotely follow patients with eye diseases "will stimulate innovation," Dr. Rich noted.

Notal Vision sponsored this study, in collaboration with the National Eye Institute. Dr. Bressler reports financial relationships with Allergan, Bausch + Lomb, Genentech, Lumenis, Notal Vision, Novartis Pharma AG, Regeneron Pharmaceuticals, Research to Prevent Blindness, The EMMES Corporation, and GlaxoSmithKline. Dr. Dugel reports financial relationships with Abbott Medical Optics, Acucela, Alcon Laboratories, Alimera Sciences, Allergan, ArticDx, Digisight, Genentech, LUX, Macusight, Neovista, Ophthotech, Ora, Regeneron, and ThromGenics. Dr. Rich has disclosed no relevant financial relationships.

American Academy of Ophthalmology (AAO) 2013 Annual Meeting. Presented November 16, 2013.


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