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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:55 - Any
Updated:10/14/2017
Start Date:May 2010
End Date:December 2013

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The HOME Study: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device - (HOme Monitoring of the Eye)

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:

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
We found this trial at
38
sites
Salt Lake City, Utah 84132
702
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from 98109
Salt Lake City, UT
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
2341
mi
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Durham, NC
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900 Northwest 17th Street
Miami, Florida 33136
2730
mi
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Miami, FL
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Atlanta, Georgia 30322
2180
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Atlanta, GA
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Baltimore, Maryland
2328
mi
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Baltimore, MD
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Baltimore, Maryland 21237
2332
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Baltimore, MD
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Boston, Massachusetts
2485
mi
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Boston, MA
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Camp Hill, Pennsylvania 17011
2282
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Camp Hill, PA
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Charlotte, North Carolina 28210
2284
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Charlotte, NC
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Chevy Chase, Maryland 20815
2317
mi
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Chevy Chase, MD
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Cleveland, Ohio 44122
2029
mi
from 98109
Cleveland, OH
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
2024
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Cleveland, OH
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Dallas, Texas 75231
1678
mi
from 98109
Dallas, TX
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Decatur, Georgia 30030
2182
mi
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Decatur, GA
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Denver, Colorado 80230
1025
mi
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Denver, CO
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Detroit, Michigan 48201
1932
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Detroit, MI
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Grand Rapids, Michigan 49546
1800
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Grand Rapids, MI
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Hershey, Pennsylvania 17033
2294
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Hershey, PA
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Houston, Texas 77030
1892
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Houston, TX
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Jacksonville, Florida 32209
2449
mi
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Jacksonville, FL
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La Jolla, California 92093
1049
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La Jolla, CA
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4 Princess Road
Lawrence-ville, New Jersey 08648
2383
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Lawrence-ville, NJ
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Lexington, Kentucky 40509
2010
mi
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Lexington, KY
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Little Rock, Arkansas 72205
1779
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Little Rock, AR
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Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
974
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Loma Linda, CA
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Louisville, Colorado 80027
1004
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Louisville, CO
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Lubbock, Texas 79424
1442
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Lubbock, TX
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
1616
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Madison, WI
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Memphis, Tennessee 38103
1864
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Memphis, TN
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Milwaukee, Michigan 53226
1681
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Milwaukee, MI
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New Haven, Connecticut
2432
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New Haven, CT
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Philadelphia, Pennsylvania 19104
2371
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15213
2134
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Pittsburgh, PA
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Royal Oak, Michigan 48073
1922
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Royal Oak, MI
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
627
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Sacramento, CA
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Sarasota, Florida 34239
2554
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Sarasota, FL
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Slingerlands, New York 12159
2348
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Slingerlands, NY
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Traverse City, Michigan 49686
1750
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Traverse City, MI
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