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


Status: Active, not recruiting
Keywords: ForeseeHome Device , AMD
IRB Number: 00043930
Specialty: Ophthalmology, Ophthalmology, Ophthalmology
Sub Specialties: Retinal Diseases, Geriatric Ophthalmology,

Brief Summary

The ForeseeHome is a device designed to monitor AMD-associated visual abnormalities. The ForeseeHome is based on a personal computer application which uses special hardware to allow testing, one eye at a time, at home. The purpose of this study is to determine if home monitoring using the ForeseeHome device in participants at high risk of progression to neovascular AMD improves detection of progression to choroidal neovascularization (CNV) when compared to standard care.

Principal Investigator: Paul Bernstein
Department: Ophthalmology-Services
Co Investigator: Albert Vitale
Co Investigator: Mary Elizabeth Hartnett
Co Investigator: Mike Teske

Contact Information

Name:Susan Allman
Phone: 801-581-5142
Email: susan.allman@hsc.utah.edu

Inclusion Criteria

Participants will be enrolled over a 20- to 24-month period and must meet the following criteria:
1. Male or female Age-Related Eye Disease 2 (AREDS2) participant 55 years of age or older who is actively being followed in AREDS2 and is expected to continue until the end of AREDS2.

For selected sites, including this site, the sponsor will allow the enrollment of non-AREDS2 participants. These participants should meet the same major eligibility criteria as those met by AREDS2 participants at the time of initial entry into AREDS2 and must be enrolled by an AREDS2 physician. They must be between 55 and 85 years of age and have bilateral large drusen (greater than or equal to 125 microns) or large drusen in the posterior pole in one eye and advanced AMD in the fellow eye as determined by the AREDS2 ophthalmologist.
2. Participant must be English speaking and understand and sign the protocol’s informed consent document.
3.  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).
4. 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.
5. Study eye(s) must have best corrected visual acuity 20/60 or better (at least 54 letters).
6. Ocular media sufficient to allow adequate quality fundus photography.
7. Participant must be willing to have name and contact information provided to Notal Vision. Participants may be contacted as part of the study for the following reasons:
a. Notal Vision will send the device directly to the address provided by the participant. In addition the participant will be able to call the ForeseeHome Call Center to receive technical support with the device.
b. Monitoring Center staff may call participants in the event that they do not transmit data at least twice a week.
c. Notal Vision will mail a report to participants at their home address, at least quarterly, regarding the frequency of their usage of the device.
d. The monitoring center will call participants to notify them if any of the following occur:
i. During the learning period, the participant is unable to establish a baseline in a study eye with the device, indicating no dynamic range for effective monitoring.
ii. During the learning period, the received data for a study eye is inconsistent, indicating a non-reliable test pattern.
iii. During the usage period, test results for a study eye suggest that a noticeable change has occurred.
iv. During the usage period, a series of tests were classified as unreliable in a study eye.

8. Participant must consent to be examined by the AREDS2 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.
9. If randomized to the device monitoring arm, participant must take the device with them if staying somewhere else other than their primary residence for 14 days or more.

Exclusion Criteria

1. Participant has evidence of macular or retinal disorders other than AMD in the study eye(s) such as:

a. Diabetic retinopathy (unless retinopathy is limited to fewer than 10 microaneurysms and/or small retinal hemorrhages).

b. Angioid streaks.

c. Central serous choroidopathy.

d.Surface wrinkling retinopathy (epiretinal membrane) that is more severe than mild surface wrinkling retinpathy.

e. Optic atrophy.

f. Pigmentary abnormalities considered by the Clinical Center ophthalmologist to be less typical of AMD than of some other condition, such as pattern dystrophy or chronic central serous retinopathy.

g. Myopic crescent of the optic disc the width of which is greater than or equal to 50% of the longest diameter of the disc, or pigmentary abnormalities in the posterior pole considered by the clinic ophthalmologist more likely to be due to myopia than to AMD.

h. Macular hole or pseudohole.

i. Retinal vein occlusion, active uveitis, presumed ocular histoplasmosis syndrome, other sight-threatening retinopathies, and other retinal degenerations, significant explained or unexplained visual field loss, or any other type of retinopathy or  retinal degeneration.

j. A choroidal nevus within 2 DD of the center of the macula associated wtih depigmentation or overlying atypical drusen.

k. Other ocular diseases or conditions, the presence of which may now or in the future complicate evaluation of AMD.

l. Amblyopia (in study eye only)

2. Participant has known adverse reaction to fluorescein dye and refuses further fluorescein angiograms.
3. Participant is receiving evaluation by an eye care professional more frequently than every 4 months.
4. Non-AREDS2 participant currently enrolled in another study that may likely affect adherence with the ForeseeHome study.

5. 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. Examples are radial keratotomy, traveculectomy, cryosurgery (except to repair a peripheral retinal hole), lamellar keratoplasty, pterygium surgery that affects or threatens the visual axis, radiation for ocular tumor, or repair of corneal or sclera laceration. Cataract surgery more than one month prior to randomization is not an exclusion criterion unless complicated by a condition that is causing or is likely to cause a decrease in visual acuity. Laser photocoagulation for drusen and non-choroidal neovascularization in the non-study eye will not be exclusion factors.

6. Chronic requirement for any systemic or ocular medication administered for other diseases such as glaucoma and known to be toxic to the retina or optic nerve, such as:

a. Deferoxamine

b. Chlroroquine/Hydroxychloroquine (Plaquinil)

c. Tamoxifen

d. Chlorpromazine

e. Phenothiazines

f. Chronic systemic steroid use of at least 10 mg per day or more

g. Ethambutol

7. Cataract surgery within one month of randomization