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

Notal Vision

Status: Completed

Conditions: Age Related Macular Degeneration

Treatments: Diagnostic Test: ForeseeHome AMD Monitoring Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01103505

ForeseeHome AREDS2

Details and patient eligibility

About

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.

Full 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:

Enrollment: 1,520 patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,520 participants in 2 patient groups

ForeseeHome AMD Monitoring Device

Other group

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

Treatment:

Diagnostic Test: ForeseeHome AMD Monitoring Device

Standard care alone (control) arm

No Intervention group

Description:

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