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Age Related Macular DegenerationAREDSNCT01103505

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

A study testing ForeseeHome AMD Monitoring Device in people with Age Related Macular Degeneration, run by Notal Vision Ltd. at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Age Related Macular Degeneration
What is being tested?
ForeseeHome AMD Monitoring Device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,520 participants
Where
38 sitesUnited States
Study dates
May 2010to Dec 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Emory Univ. Eye Center

    Atlanta, Georgia, 30322

  • Elman Retina Group, PA

    Baltimore, Maryland, 21237

  • Wilmer Eye Institute

    Baltimore, Maryland, 21287

  • Ophthalmic Cons. of Boston

    Boston, Massachusetts

  • Pennsylvania Retina Specialists, P.C.

    Camp Hill, Pennsylvania, 17011

  • Charlotte Eye Ear Nose and Throat Assoc

    Charlotte, North Carolina, 28210

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Case Western Reserve Univ.

    Cleveland, Ohio, 44106

  • Retina Assoc. of Cleveland

    Cleveland, Ohio, 44122

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Georgia Retina, P.C.

    Decatur, Georgia, 30030

  • Colorado Retina Assoc.

    Denver, Colorado, 80230

  • Kresge Eye Institute

    Detroit, Michigan, 48201

  • Duke Univ.

    Durham, North Carolina, 27710

  • Vision Research Foundation

    Grand Rapids, Michigan, 49546

  • Penn State M.S. Hershey Med Ctr

    Hershey, Pennsylvania, 17033

  • Retina Consult. of Houston

    Houston, Texas, 77030

  • Univ. of Florida Health Science Center

    Jacksonville, Florida, 32209

  • Shiley Eye Center - UCSD

    La Jolla, California, 92093

  • Delaware Valley Retina Associates

    Lawrenceville, New Jersey

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • Jones Eye Institute - UAMS

    Little Rock, Arkansas, 72205

  • Loma Linda Univ.

    Loma Linda, California, 92354

  • Eldorado Retina Associates

    Louisville, Colorado, 80027

  • Texas Retina Associates

    Lubbock, Texas, 79410

  • Univ. of Wisconsin

    Madison, Wisconsin, 53705

  • Univ. of Tennessee HSC

    Memphis, Tennessee, 38103

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Yale Univ. Eye Center

    New Haven, Connecticut

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • UPMC Eye Center

    Pittsburgh, Pennsylvania, 15213

  • Vision Research Foundation

    Royal Oak, Michigan, 48073

  • Univ. of California, Davis

    Sacramento, California, 95817

  • John Moran Eye Center, Univ. of Utah

    Salt Lake City, Utah, 84132

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Retina Research Foundation

    Slingerlands, New York, 12159

  • Vision Research Foundation

    Traverse City, Michigan, 49684

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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:

Being tested
ForeseeHome AMD Monitoring Device
Keywords
AMD, CNV
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ForeseeHome AMD Monitoring DeviceDiagnostic 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

Study groups in NCT01103505
Study groupRoleWhat they receive
ForeseeHome AMD Monitoring DeviceOtherParticipants in the device monitoring arm will receive a packed device at home, with instructions to install and connect the device to a modem as well as instructions for daily use of the device in addition to standard care
Receives: Diagnostic Test: ForeseeHome AMD Monitoring Device
Standard care alone (control) armNo interventionStandard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (4)

  1. 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

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionOct 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01103505
Sponsor's protocol ID
ForeseeHome AREDS2
Acronym
AREDS
Status last verified
Jul 2019
First submitted
12 Apr 2010
Last updated
30 Jul 2019
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ForeseeHome AMD Monitoring Device in people with Age Related Macular Degeneration, run by Notal Vision Ltd. at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01103505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.

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