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Michael Elman, Susan Bressler, Traci Clemons, Emily Chew, ; ForeseeHome in AREDS2-Home Monitoring of AMD patients: Study Design, Enrollment, Baseline Characteristics and Initial Device Usage. Invest. Ophthalmol. Vis. Sci. 2013;54(15):6273.
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To describe the design of the ForeseeHome-AREDS2 trial and report patient enrollment numbers, including screen failures, and frequency of home device monitoring during initial 3 months.
Patients at moderate to high risk of progression to choroidal neovascularization (CNV) associated with AMD were enrolled at retina clinics into a randomized trial to determine if home monitoring using the comprehensive visual field and tele-monitoring solution based on the ForeseeHome (FH) device improves detection of progression to CNV when compared with standard care. The primary objective is to determine whether home monitoring will lead to improved best corrected visual acuity (BCVA) at CNV diagnosis compared with standard of care. Secondary outcomes include time to CNV, CNV lesion characteristics, sensitivity/specificity of the device and BCVA 3 and 12 months after initiation of anti-VEGF treatment. The in-clinic screening exam required meeting ocular eligibility and successfully completing a test with the FH device. Subjects who passed the screening were randomized to standard care monitoring or standard care plus FH monitoring. Following shipment of the device, remote assistance with self-installation and training on the device followed. An initial series of tests were used to establish a baseline measurement for subsequent monitoring. Eyes that established a baseline entered the monitoring phase during which daily testing is recommended.
1520 of 1970 (77%) participants screened were enrolled in 44 clinical centers. Mean age of enrolled subjects was 72.5±7.5; mean baseline BCVA of study eyes was Snellen equivalent 20/25. The most common reason subjects failed screening was an inability to pass the device qualification test (76%) at the clinic. 1313 eyes of 763 subjects were randomized to the FH monitoring arm, among which 107 eyes (8.1%) failed to establish baseline values. 10 eyes of 6 pts (<1%) of device assigned participants stopped device monitoring within the 1st 90 days of monitoring, whereas the mean weekly device usage was 4.75 (± 1.77) throughout this period.
The successful enrollment, randomization and stable rates of initial FH compliance are encouraging. The study will help clarify the optimal strategies for monitoring patients with intermediate AMD for early detection of CNV.
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