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

NCT01103505 | Completed Results DMC FDA Device

• 1 other identifier: ForeseeHome AREDS2
• Study Type: interventional
• Target: 1,520
• Locations: 1 country
• Sites: 38

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.

Conditions

Age Related Macular Degeneration

Keywords

AMD; CNV

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (4)

• Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection

  2 years

• Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV

  2 years

• Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV

  2 years

• Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV

  2 years

Study Arms (2)

ForeseeHome AMD Monitoring Device

OTHER

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

Standard care alone (control) arm

NO INTERVENTION

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

Interventions

ForeseeHome AMD Monitoring Device DIAGNOSTIC_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

ForeseeHome AMD Monitoring Device

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Notal Vision Ltd.: lead

Study Sites (38)

Jones Eye Institute - UAMS

Little Rock, Arkansas, 72205, United States

Location

Shiley Eye Center - UCSD

La Jolla, California, 92093, United States

Location

Loma Linda Univ.

Loma Linda, California, 92354, United States

Location

Univ. of California, Davis

Sacramento, California, 95817, United States

Location

Colorado Retina Assoc.

Denver, Colorado, 80230, United States

Location

Eldorado Retina Associates

Louisville, Colorado, 80027, United States

Location

Yale Univ. Eye Center

New Haven, Connecticut, United States

Location

Univ. of Florida Health Science Center

Jacksonville, Florida, 32209, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Emory Univ. Eye Center

Atlanta, Georgia, 30322, United States

Location

Georgia Retina, P.C.

Decatur, Georgia, 30030, United States

Location

Retina Associates of Kentucky

Lexington, Kentucky, 40509, United States

Location

Elman Retina Group, PA

Baltimore, Maryland, 21237, United States

Location

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Retina Group of Washington

Chevy Chase, Maryland, 20815, United States

Location

Ophthalmic Cons. of Boston

Boston, Massachusetts, United States

Location

Kresge Eye Institute

Detroit, Michigan, 48201, United States

Location

Vision Research Foundation

Grand Rapids, Michigan, 49546, United States

Location

Vision Research Foundation

Royal Oak, Michigan, 48073, United States

Location

Vision Research Foundation

Traverse City, Michigan, 49684, United States

Location

Delaware Valley Retina Associates

Lawrenceville, New Jersey, United States

Location

Retina Research Foundation

Slingerlands, New York, 12159, United States

Location

Charlotte Eye Ear Nose and Throat Assoc

Charlotte, North Carolina, 28210, United States

Location

Duke Univ.

Durham, North Carolina, 27710, United States

Location

Case Western Reserve Univ.

Cleveland, Ohio, 44106, United States

Location

Retina Assoc. of Cleveland

Cleveland, Ohio, 44122, United States

Location

Pennsylvania Retina Specialists, P.C.

Camp Hill, Pennsylvania, 17011, United States

Location

Penn State M.S. Hershey Med Ctr

Hershey, Pennsylvania, 17033, United States

Location

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Univ. of Tennessee HSC

Memphis, Tennessee, 38103, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina Consult. of Houston

Houston, Texas, 77030, United States

Location

Texas Retina Associates

Lubbock, Texas, 79410, United States

Location

John Moran Eye Center, Univ. of Utah

Salt Lake City, Utah, 84132, United States

Location

Univ. of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• Sponsor Home Page
• AREDS2 page

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Grace Chang, MD, PhD
• Organization: Notal Vision

Grace.Chang@NotalVision.com

571-719-6416

Study Officials

• Emily Chew, MD

  National Eye Institute (NEI)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 14, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 30, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-07

Locations

US (38)