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:

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