HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device

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:

• ForeseeHome AMD Monitoring Device (Diagnostic test): 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 outcomes

• Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization [2 years]: 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.

Secondary outcomes

• Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection [2 years]: Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm
• Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV [2 years]: 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.
• Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV [2 years]: 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.
• Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV [2 years]: 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.

Sex: All, ages: 55 Years to any

INCLUSION CRITERIA:

* Male or female participant between 55 and 90 years of age. Participants must have bilateral large drusen (at least 125 micron), or large drusen in the posterior pole in one eye (study eye) and advanced AMD (neovascular AMD or central geographic atrophy) in the fellow eye as determined by their study ophthalmologist. Likelihood, willingness, and ability to return for multiple visits (potentially within the same month) for at least 2 years.
* Participant must be English speaking and understand and sign the protocol's informed consent document.
* Participant must be able to successfully demonstrate their ability to comprehend instructions and use of the ForeseeHome device (a ForeseeHome device will be available at the clinic for the participant to demonstrate their ability).
* Participant's address to which the ForeseeHome device will be sent, if randomized to the device monitoring arm, must be located in the U.S.A.
* Study eye(s) must have best corrected visual acuity 20/60 or better (at least 54 letters).
* Ocular media sufficient to allow adequate quality fundus photography.
* Participant must be willing to have name and contact information provided to Notal Vision.
* Participant must consent to be examined by the study ophthalmologist when changes in symptoms are detected by the home-device or by standard of care or when unreliable test results occur during the usage period.
* If randomized to the device monitoring arm, participant must agree to take the device with them if staying somewhere else other than their primary residence for 14 days or more.

EXCLUSION CRITERIA:

* Participant has evidence of macular or retinal disorders other than AMD in the study eye(s).
* Participant has known adverse reaction to fluorescein dye or refuses further fluorescein angiograms.
* Participant's eye is receiving (or is expected to receive) an eye examination on a continuing basis by an eye care professional more frequently than every four months
* NonAREDS2 participant currently enrolled in another study that may likely affect adherence with The HOME Study
* Previous retinal or other ocular surgical procedures, the effects of which may now or in the future complicate assessment of the progression of AMD in the study eye.
* Chronic requirement for any systemic or ocular medication administered for other diseases
* Cataract surgery within one month of randomization.
* Participant that has any condition that would make adherence to study follow up procedures for at least one year difficult or unlikely

Participant flow

Outcome results

• Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization (Primary), Mean, LogMAR letters (ETDRS): ForeseeHome + Standard Care at CNV Progression -7.4 +/- 11.4; Standard Care Alone (Control) at CNV Progression -12.6 +/- 16.5
• Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection (Secondary), Number, percentage of patients: Device Monitoring Arm 87; Standard Care (Control) Arm 64
• Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV (Secondary), Median, Disc Areas: Device Monitoring Arm 0.23 (0 to 0.91); Standard Care (Control) Arm 0.70 (0 to 1.50)
• Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV (Secondary), Median, Disc Areas: Device Monitoring Arm 0.17 (0 to 0.69); Standard Care (Control) Arm 0.60 (0 to 1.50)
• Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV (Secondary), Median, Disc Areas: Device Monitoring Arm 0.55 (0 to 1.15); Standard Care (Control) Arm 0.90 (0 to 2.20)

Adverse events

• Emily Chew, MD, Study chair, National Eye Institute (NEI)