Randomized trial of the ForeseeHome monitoring device for early detection of neovascular age-related macular degeneration. The HOme Monitoring of the Eye (HOME) study design — HOME Study report number 1

Abstract

Objective

To evaluate the effects of a home-monitoring device with tele-monitoring compared with standard care in detection of progression to choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), the leading cause of blindness in the US.

Patients and methods

Participants, aged 55 to 90 years, at high risk of developing CNV associated with AMD were recruited to the HOme Monitoring of Eye (HOME) Study, an unmasked, multi-center, randomized trial of the ForeseeHome (FH) device plus standard care vs. standard care alone. The FH device utilizes preferential hyperacuity perimetry and tele-monitoring to detect changes in vision function associated with development of CNV, potentially prior to symptom and visual acuity loss. After establishing baseline measurements, subsequent changes on follow-up are detected by the device, causing the monitoring center to alert the clinical center to recall participants for an exam. Standard care consists of instructions for self-monitoring visual changes with subsequent self-report to the clinical center. The primary objective of this study is to determine whether home monitoring plus standard care in comparison with standard care alone, results in earlier detection of incident CNV with better present visual acuity. The primary outcome is the decline in visual acuity at CNV diagnosis from baseline. Detection of CNV prior to substantial vision loss is critical as vision outcome following anti-angiogenic therapy is dependent on the visual acuity at initiation of treatment.

Discussion

HOME Study is the first large scale study to test the use of home tele-monitoring system in the management of AMD patients.

Introduction

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in the United States [1], [2] and in populations of northern European descent in the developed world [3]. Blindness in advanced AMD occurs from the development of choroidal neovascularization (CNV) and/or geographic atrophy affecting the center of the fovea. While CNV occurs in only 10%–15% of all persons with AMD, it accounts for more than 80% of cases of severe central vision loss associated with AMD [4].

Current therapy for neovascular AMD, intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents, such as bevacizumab, ranibizumab and aflibercept, can potentially stabilize visual acuity in 95% of eyes [5], [6], [7], [8], [9], [10]. The main predictor for visual acuity outcome following anti-VEGF treatment is the visual acuity at the time of initiation of CNV therapy [11], [12], [13]. Patients with worse visual acuity at initiation of treatment were more likely to gain more letters of vision but their final visual acuity tended to be worse than those who started with good visual acuity and gained fewer letters following treatment [11], [12], [13].

Current monitoring of patients at risk for CNV development consists of periodic in-office examinations at varying intervals by ophthalmologists and optometrists with the recommendation for self-monitoring of visual function including either new onset or changes in existing symptoms. This may include the use of an Amsler grid. Such monitoring strategies yielded visual acuity of 20/40 or better at the initial detection of CNV in only 13 to 36% of new onset CNV [11], [14]. Increasing time interval between onset of symptoms and initiation of treatment resulted in markedly decreased visual acuities both at presentation of CNV and following anti-VEGF treatment [15]. Detection of the CNV prior to significant vision loss is essential to maximize successful visual outcomes following treatment.

This report describes the design of the HOme Monitoring of the Eye (HOME) Study, a Phase 3, unmasked, randomized trial evaluating the role of home monitoring with the ForeseeHome (FH) device plus standard care (referred from here as FH monitoring) compared to standard care alone for eyes at risk of developing CNV. Study subjects were enrolled in 44 retina clinics participating in the Age-Related Eye Disease Study 2 (AREDS2), a randomized trial of nutrient supplements. The ForeseeHome monitoring device utilized macular visual field testing and tele-monitoring. The basis for this test is preferential hyperacuity (or vernier acuity) perimetry which potentially detects the earliest functional abnormalities associated with CNV, prior to patient's awareness of symptoms or visual acuity changes. Such changes transmitted to the monitoring center triggered alerts to the physicians about the potential early development of CNV. Participants were then contacted for exams. This strategy, paired with standard care was compared with standard care alone, which consisted of instructions to regular monocular self-monitoring for visual changes with subsequent self-report to the physician. The hypothesis tested was that home monitoring would detect the onset of neovascular AMD earlier with better visual acuity (a smaller decrease in visual acuity compared with baseline) at CNV detection compared with the standard of care alone arm. The study was registered at ClinicalTrials.gov with the identification NCT01103505.