Home Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the Foresee Home Device
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| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Age-Related Macular Degeneration |
| Purpose: |
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Background:
- In the wet form of age-related macular degeneration (AMD), new blood vessels grow and
cause fluid leaks into the retina, which leads to loss of vision. Some studies suggest that
if the development of new blood vessels (choroidal neovascularization, or CNV) is detected
early, treatment could be started sooner, which may help prevent visual loss. One possible
method of early detection is the ForeseeHome device, which is part of a program designed to
allow individuals to monitor their eyes for vision changes at home. Researchers are
interested in comparing eye disease progression in people using the ForeseeHome device with
those not using the device.
Objectives:
- To determine if home monitoring of age-related macular degeneration using the ForeseeHome
device can help detect progression of disease earlier than standard care.
Eligibility:
- Individuals at least 55 years of age who are participating in the AREDS2 study, are at
risk for choroidal neovascularization in at least one eye, and are able to use the
ForeseeHome device correctly.
Design:
- Participants will be screened with a physical examination, medical history, and eye
examinations. Participants will also be introduced to the device in order to determine
if they will be able to use it for the duration of the study.
- Half of the study participants will receive the ForeseeHome device; the other half will
have standard of care monitoring. Participants will be asked only to monitor the eye(s)
that are at risk for progression to wet AMD.
- Participants assigned to the device monitoring group will receive the ForeseeHome
device, a personal monitor that has a head unit with a viewer and internal screen, and
a modem connected to a telephone cord. This cord must be attached to a land telephone
line so that it can send data to the sponsor. Set-up instructions will be included with
the device.
- Participants will use the ForeseeHome device daily by looking at a screen and
identifying certain patterns presented on the screen. The test takes about 4 minutes
for each eye at risk. Test results will be transmitted by the modem to the sponsor, and
the results will be reviewed by trained personnel. If the testing suggests a change in
eye condition, participants and their AREDS2 clinic site will be notified by telephone
and asked to schedule an appointment for an examination within 3 days of the call.
- Participants in the standard care group should continue to have regular clinic visits
and the required AREDS2 study visits, and will monitor eye symptoms using the
instructions provided by the eye doctor for identifying possible CNV. Participants
should contact the AREDS2 clinic promptly and come to the clinic within 3 days of any
changes in vision.
- The ForeseeHome device will be returned (1) after progression to CNV of the eye at
risk, (2) at the end of the study, or (3) if use of the device produces unreliable
results such that monitoring with the device becomes unreliable.
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| Study Summary: |
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AREDS2 is a multi-center Phase III randomized clinical trial designed to assess the effects
of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or
omega-3 LCPUFAs as a treatment for AMD, cataract and moderate vision loss. In addition to
this objective, the study will provide information on the clinical course, prognosis, and
risk factors for development and progression of both AMD and cataract. Other study goals
include the evaluation of eliminating beta-carotene and/or reducing zinc in the original
AREDS formulation on the progression and development of AMD. AREDS2 will also seek to
validate the fundus photographic AMD scale developed from AREDS.
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 aim
of the current ancillary study is to investigate the benefits of long-term monitoring with
the ForeseeHome for patients at high risk of developing CNV. 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.
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| Criteria: |
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- INCLUSION CRITERIA:
- Male or female Age-Related Eye Disease 2 (AREDS2) participant 55 years of age or
older who is actively being followed in AREDS2 and is expected to continue until the
end of AREDS2.
- Participant must be English speaking and understand and sign the protocol's informed
consent document.
- Participant does not have advanced AMD (neovascular AMD or central geographic
atrophy) in at least 1 eye. The eye(s) that does not have advanced AMD must have at
least intermediate AMD and will be the study eye(s).
- 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 must have a working phone land line in the participant's main residence.
- 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 seven days
or more.
- Participant has some previous experience using equipment with similar user
interfaces, e.g. pointer mouse devices on a personal computer.
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.
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| NCT ID: |
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NCT01314430 |
| Primary Contact: |
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Principal Investigator
Wai T Wong, M.D.
National Eye Institute (NEI)
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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