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Trial record 22 of 32 for:    retina associates of kentucky

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

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ClinicalTrials.gov Identifier: NCT01103505
Recruitment Status : Completed
First Posted : April 14, 2010
Results First Posted : July 16, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Notal Vision Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Diagnostic Test: ForeseeHome AMD Monitoring Device Not Applicable

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:

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The HOME Study: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device - (HOme Monitoring of the Eye)
Study Start Date : May 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ForeseeHome AMD Monitoring Device
Participants 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
Diagnostic Test: ForeseeHome AMD Monitoring Device
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

No Intervention: Standard care alone (control) arm
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams



Primary Outcome Measures :
  1. Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization [ Time Frame: 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 Outcome Measures :
  1. Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection [ Time Frame: 2 years ]
    Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm

  2. Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV [ Time Frame: 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.

  3. Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV [ Time Frame: 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.

  4. Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV [ Time Frame: 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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103505


  Hide Study Locations
Locations
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United States, Arkansas
Jones Eye Institute - UAMS
Little Rock, Arkansas, United States, 72205
United States, California
Shiley Eye Center - UCSD
La Jolla, California, United States, 92093
Loma Linda Univ.
Loma Linda, California, United States, 92354
Univ. of California, Davis
Sacramento, California, United States, 95817
United States, Colorado
Colorado Retina Assoc.
Denver, Colorado, United States, 80230
Eldorado Retina Associates
Louisville, Colorado, United States, 80027
United States, Connecticut
Yale Univ. Eye Center
New Haven, Connecticut, United States
United States, Florida
Univ. of Florida Health Science Center
Jacksonville, Florida, United States, 32209
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
United States, Georgia
Emory Univ. Eye Center
Atlanta, Georgia, United States, 30322
Georgia Retina, P.C.
Decatur, Georgia, United States, 30030
United States, Kentucky
Retina Associates of Kentucky
Lexington, Kentucky, United States, 40509
United States, Maryland
Elman Retina Group, PA
Baltimore, Maryland, United States, 21237
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
Retina Group of Washington
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Ophthalmic Cons. of Boston
Boston, Massachusetts, United States
United States, Michigan
Kresge Eye Institute
Detroit, Michigan, United States, 48201
Vision Research Foundation
Grand Rapids, Michigan, United States, 49546
Vision Research Foundation
Royal Oak, Michigan, United States, 48073
Vision Research Foundation
Traverse City, Michigan, United States, 49684
United States, New Jersey
Delaware Valley Retina Associates
Lawrenceville, New Jersey, United States
United States, New York
Retina Research Foundation
Slingerlands, New York, United States, 12159
United States, North Carolina
Charlotte Eye Ear Nose and Throat Assoc
Charlotte, North Carolina, United States, 28210
Duke Univ.
Durham, North Carolina, United States, 27710
United States, Ohio
Case Western Reserve Univ.
Cleveland, Ohio, United States, 44106
Retina Assoc. of Cleveland
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Pennsylvania Retina Specialists, P.C.
Camp Hill, Pennsylvania, United States, 17011
Penn State M.S. Hershey Med Ctr
Hershey, Pennsylvania, United States, 17033
Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
UPMC Eye Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Univ. of Tennessee HSC
Memphis, Tennessee, United States, 38103
United States, Texas
Texas Retina Associates
Dallas, Texas, United States, 75231
Retina Consult. of Houston
Houston, Texas, United States, 77030
Texas Retina Associates
Lubbock, Texas, United States, 79410
United States, Utah
John Moran Eye Center, Univ. of Utah
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
Univ. of Wisconsin
Madison, Wisconsin, United States, 53705
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Notal Vision Ltd
Investigators
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Study Chair: Emily Chew, MD National Eye Institute (NEI)

Additional Information:
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Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT01103505     History of Changes
Obsolete Identifiers: NCT01314430
Other Study ID Numbers: ForeseeHome AREDS2
First Posted: April 14, 2010    Key Record Dates
Results First Posted: July 16, 2019
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Notal Vision Ltd:
AMD
CNV

Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases