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

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ForeseeHome AMD Monitoring Device
Sponsored by
Notal Vision Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age Related Macular Degeneration focused on measuring AMD, CNV

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jones Eye Institute - UAMS
  • Shiley Eye Center - UCSD
  • Loma Linda Univ.
  • Univ. of California, Davis
  • Colorado Retina Assoc.
  • Eldorado Retina Associates
  • Yale Univ. Eye Center
  • Univ. of Florida Health Science Center
  • Bascom Palmer Eye Institute
  • Sarasota Retina Institute
  • Emory Univ. Eye Center
  • Georgia Retina, P.C.
  • Retina Associates of Kentucky
  • Elman Retina Group, PA
  • Wilmer Eye Institute
  • Retina Group of Washington
  • Ophthalmic Cons. of Boston
  • Kresge Eye Institute
  • Vision Research Foundation
  • Vision Research Foundation
  • Vision Research Foundation
  • Delaware Valley Retina Associates
  • Retina Research Foundation
  • Charlotte Eye Ear Nose and Throat Assoc
  • Duke Univ.
  • Case Western Reserve Univ.
  • Retina Assoc. of Cleveland
  • Pennsylvania Retina Specialists, P.C.
  • Penn State M.S. Hershey Med Ctr
  • Scheie Eye Institute
  • UPMC Eye Center
  • Univ. of Tennessee HSC
  • Texas Retina Associates
  • Retina Consult. of Houston
  • Texas Retina Associates
  • John Moran Eye Center, Univ. of Utah
  • Univ. of Wisconsin
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

ForeseeHome AMD Monitoring Device

Standard care alone (control) arm

Arm Description

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

Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
April 12, 2010
Last Updated
July 16, 2019
Sponsor
Notal Vision Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01103505
Brief Title
HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device
Acronym
AREDS
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 Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Notal Vision Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
AMD, CNV

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ForeseeHome AMD Monitoring Device
Arm Type
Other
Arm Description
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
Arm Title
Standard care alone (control) arm
Arm Type
No Intervention
Arm Description
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams
Intervention Type
Diagnostic Test
Intervention Name(s)
ForeseeHome AMD Monitoring Device
Intervention Description
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
Primary Outcome Measure Information:
Title
Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection
Description
Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm
Time Frame
2 years
Title
Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV
Description
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.
Time Frame
2 years
Title
Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV
Description
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.
Time Frame
2 years
Title
Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Chew, MD
Organizational Affiliation
National Eye Institute (NEI)
Official's Role
Study Chair
Facility Information:
Facility Name
Jones Eye Institute - UAMS
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Shiley Eye Center - UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Loma Linda Univ.
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Univ. of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Colorado Retina Assoc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Eldorado Retina Associates
City
Louisville
State/Province
Colorado
ZIP/Postal Code
80027
Country
United States
Facility Name
Yale Univ. Eye Center
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Univ. of Florida Health Science Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Emory Univ. Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Georgia Retina, P.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Elman Retina Group, PA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Ophthalmic Cons. of Boston
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Vision Research Foundation
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Vision Research Foundation
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Vision Research Foundation
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Delaware Valley Retina Associates
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
Retina Research Foundation
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Assoc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke Univ.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Case Western Reserve Univ.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Retina Assoc. of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Pennsylvania Retina Specialists, P.C.
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Penn State M.S. Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Univ. of Tennessee HSC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consult. of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Retina Associates
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
John Moran Eye Center, Univ. of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Univ. of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.notalvision.com
Description
Sponsor Home Page

Learn more about this trial

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

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