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

Completed · Not applicable

Conditions studied: Age Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT01103505

Run by

Notal Vision Ltd.

People needed

1520

Starts

2010-05-01

Expected to finish

2013-12-01

Last updated by the study team

2019-07-30

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Jones Eye Institute - UAMS — Little Rock, Arkansas, United States
• Shiley Eye Center - UCSD — La Jolla, California, United States
• Loma Linda Univ. — Loma Linda, California, United States
• Univ. of California, Davis — Sacramento, California, United States
• Colorado Retina Assoc. — Denver, Colorado, United States
• Eldorado Retina Associates — Louisville, Colorado, United States
• Yale Univ. Eye Center — New Haven, Connecticut, United States
• Univ. of Florida Health Science Center — Jacksonville, Florida, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Emory Univ. Eye Center — Atlanta, Georgia, United States
• Georgia Retina, P.C. — Decatur, Georgia, United States
• Retina Associates of Kentucky — Lexington, Kentucky, United States
• Elman Retina Group, PA — Baltimore, Maryland, United States
• Wilmer Eye Institute — Baltimore, Maryland, United States
• Retina Group of Washington — Chevy Chase, Maryland, United States
• Ophthalmic Cons. of Boston — Boston, Massachusetts, United States
• Kresge Eye Institute — Detroit, Michigan, United States
• Vision Research Foundation — Grand Rapids, Michigan, United States
• Vision Research Foundation — Royal Oak, Michigan, United States
• Vision Research Foundation — Traverse City, Michigan, United States
• Delaware Valley Retina Associates — Lawrenceville, New Jersey, United States
• Retina Research Foundation — Slingerlands, New York, United States
• Charlotte Eye Ear Nose and Throat Assoc — Charlotte, North Carolina, United States
• Duke Univ. — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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