The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 improves detection of progression to choroidal neovascularization (CNV) when compared with standard care.
The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 (referred to as the ForeseeHome comprehensive solution) participants at high risk of progression to neovascular AMD improves detection of progression to choroidal neovascularization (CNV) when compared with standard care. The primary outcome of this study is presenting best corrected visual acuity (BCVA) at the time of CNV diagnosis. Secondary outcomes include time to confirmed CNV diagnosis, lesion size, lesion location (extrafoveal, juxtafoveal, or subfoveal), lesion type (occult without classic, predominantly classic or minimally classic), sensitivity and specificity, and BCVA following three consecutive months of treatment and twelve months after the initial start of CNV treatment with an intravitreal anti-VEGF agent using either ranibizumab or bevacizumab. Outcomes will be ascertained via the following specific aims:
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,520
Earlier detection of progression from intermediate dry age-related macular degeneration to CNV between routine eye exams through home diagnostic testing with the ForeseeHome AMD Monitoring device
Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
Mean change in BCVA (logMAR letters) from baseline to the time of confirmed progression to CNV in the ForeseeHome device monitoring group compared to the standard care group.
Time frame: 2 years
Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection
Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm
Time frame: 2 years
Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV
Median lesion size (total lesion area) at time of confirmed progression to CNV as measured on fluorescein angiography (FA) will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\^2.
Time frame: 2 years
Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV
Median lesion size (CNV area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\^2.
Time frame: 2 years
Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV
Median lesion size (fluid area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\^2.
Time frame: 2 years
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Jones Eye Institute - UAMS
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Shiley Eye Center - UCSD
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Loma Linda Univ.
Loma Linda, California, United States
Univ. of California, Davis
Sacramento, California, United States
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Eldorado Retina Associates
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Yale Univ. Eye Center
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Univ. of Florida Health Science Center
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