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☆
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.
Section snippets
Research design and methods
The HOME Study, an ancillary study of the Age-Related Eye Disease Study 2 (AREDS2), a long-term multicenter randomized controlled clinical trial of oral supplements, was an unmasked, randomized clinical study that enrolled both AREDS2 and non-AREDS2 participants. They were randomly assigned, 1:1, to either the FH monitoring plus standard care or the standard care alone. The Institutional Review Boards for human subject research from the individual clinical sites approved the study protocol and
Study objectives and endpoints
The primary objective of this study was to determine whether home monitoring with the preferential hyperacuity perimetry and tele-monitoring solution based on the FH device plus standard care in participants at high risk for progression to CNV results in earlier detection of progression to CNV when compared with standard care alone. Progression to CNV was determined by the investigator, based on clinical examination and ancillary office testing. Ocular images obtained for the documentation of
Discussion
The HOME Study was designed to address whether implementation of the FH device and tele-monitoring strategy plus standard care will result in earlier detection of CNV manifested by minimal impairment in the presenting visual acuity at the time of CNV diagnosis, potentially allowing for better visual function after intravitreal anti-VEGF therapy to manage the CNV. Study enrollment was completed in November 2012. The study design appeared to be feasible despite challenges to conducting such a
Conflict of interest disclosures
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.
Dr. Susan Bressler reported receiving grant and travel support from the EMMES Corporation; serving as a consultant for GlaxoSmithKline; receiving grants or grants pending from Allergan, Bayer Healthcare, Genentech, Lumenis Inc, Notal Vision Ltd, Novartis, Regeneron, Thrombogenics, and Sanofi-Aventis; receiving payment for lectures from providers of continuing medical education materials;
Acknowledgment
Emily Chew and Traci Clemons had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analyses. The investigators designed and executed the study in collaboration with the sponsors of the study. The analyses were performed independently in the Coordinating Center. The Data and Safety Monitoring Committees evaluated both the study design and the study data. The manuscript was drafted by the investigators with collaboration
References (19)
- et al.
The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing
Ophthalmology
(Jun 2011) - et al.
Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration
Ophthalmology
(2011) - et al.
Baseline predictors for one-year visual outcomes with ranibizumab or bevacizumab for neovascular age-related macular degeneration
Ophthalmology
(2013) - et al.
Subgroup analysis of the MARINA study of ranibizumab in neovascular age-related macular degeneration
Ophthalmology
(2007) - et al.
Intravitreal bevacizumab and ranibizumab for age-related macular degeneration. A multi-center, retrospective study
Ophthalmology
(2010) - et al.
A computerized method of visual acuity testing: an adaptation of the Early Treatment Diabetic Retinopathy Study testing protocol
Am J Ophthalmol
(2003) - et al.
Causes and prevalence of visual impairment among adults in the United States
Arch Ophthalmol
(2004) - et al.
Prevalence of age-related macular degeneration in the United States
Arch Ophthalmol
(2004) - et al.
2002 global update of available data on visual impairment: a compilation of population-based prevalence studies
Ophthalmic Epidemiol
(2004)
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2023, American Journal of OphthalmologyAnalysis of the Long-term Visual Outcomes of ForeseeHome Remote Telemonitoring: The ALOFT Study
2022, Ophthalmology RetinaHome vision monitoring in patients with maculopathy: Real-life study of the OdySight application
2021, Journal Francais d'OphtalmologieCitation Excerpt :It is immediately available anywhere, at any time, contrary to a dedicated OCT [7] or iPod [8], and thus an ideal tool for ensuring compliance. Consider, for example, ForeseeHome from Notal Vision [9], based on Preferential Hyperacuity Perimetry (PHP) testing. A special device for holding the patient's face is delivered to their home.
Home Monitoring of Age-Related Macular Degeneration: Utility of the ForeseeHome Device for Detection of Neovascularization
2021, Ophthalmology RetinaCitation Excerpt :Additionally, among all eyes with false-positive alerts, 9 eyes (27.3%) underwent FA at least once in the year after the first false-positive alert; 7 eyes never demonstrated CNV within the follow-up period, and 2 eyes converted within 5.1 and 6.75 months of the false-positive alert. At-home telemonitoring is a validated method for monitoring disease states across multiple specialties including cardiology, pulmonology, obstetrics, and ophthalmology.34,35,37–43 Despite this, use of home monitoring devices in clinical practice can be challenging, as evidenced by the current dataset.
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Financial Support: Financial support to the study was provided by the Notal Vision through a clinical trial agreement with the NEI (CTA-00833) and a service agreement with EMMES Corporation. The AREDS2 study is supported by the intramural program funds and contracts from the National Eye Institute/National Institutes of Health (NEI/NIH), Department of Health and Human Services, Bethesda, MD. Contract No. HHS-N-260-2005-00007-C. ADB Contract No. N01-EY-5-0007. Funds were generously contributed to these contracts by the following NIH institutes: Office of Dietary Supplements (ODS), National Center for Complementary and Alternative Medicine (NCCAM), National Institute on Aging (NIA), National Heart, Lung and Blood Institute (NHLBI), and National Institute of Neurological Disorders and Stroke (NINDS). The study medications and raw materials were provided by Alcon, Bausch and Lomb, DSM, and Pfizer.