Beginning in May, the NEI/NIH will begin recruiting 1000 patients in a cohort study, from among those participating in the AREDS2 clinical trial. Half of the recruits will be provided the Notal ForeSeeHome Device to monitor their progression from mid-to late-stage dry AMD to neovascular, or wet-stage AMD, while the other half will monitor their progress using standard care, including the Amsler Grid.
The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring of participants at high risk of progression to neovascular AMD, using the comprehensive visual field and telemedicine solution based on the ForeseeHome Device in AREDS2 (referred to as the ForeseeHome comprehensive solution), improves detection of progression to choroidal neovascularization (CNV) when compared with standard care (use of the Amsler Grid).
The primary outcome of this study will be to present 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.
A further secondary outcome will be to determine if vision can be preserved by earlier detection of CNV as compared to its detection at a later stage with standard care.
The study is planned to run for two years and is expected to be completed by December 2012.
The official name of the clinical trial cohort is:
(A link to the web page containing additional information about the cohort study is provided above.)
Outcomes will be ascertained via the following specific aims:
Arms, Groups and Cohorts in this Clinical Trial
* : Device monitoring arm
o 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.
* : Standard care (control) arm
o Standard care instruction per clinic routine for home vision monitoring (Amsler Grid) to detect progression of AMD.
* Participants will be enrolled over a 9 to 12-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.
* 2. Participant must be English speaking and understand and sign the protocol's informed consent document.
* 3. Participant does not have advanced AMD (neovascular AMD or central geographic atrophy) in at least 1 eye. The eye(s) that does not have advanced AMD must have at least intermediate AMD and will be the study eye(s).
* 4. 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).
* 5. Participant must have a working phone land line in the participant's main residence.
* 6. 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.
* 7. Study eye(s) must have best corrected visual acuity 20/60 or better (at least 54 letters).
* 8. Ocular media sufficient to allow adequate quality fundus photography.
* 9. Participant must be willing to have name and contact information provided to Notal Vision. Participants may be contacted as part of the study
* 10. 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.
* 11. If randomized to the device monitoring arm participant must take the device with them if staying somewhere else other than their primary residence for 7 days or more.
* 12. Participant has some experience using a computer.
The following are exclusion criteria for prospective study participants:
* 1. Participant has evidence of macular or retinal disorders other than AMD in the study eye(s).
* 2. Participant has known adverse reaction to fluorescein dye.
* 3. Participant is seen at the clinic more frequently than every 4 months.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 55 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Notal Vision Ltd
Overall Clinical Trial Officials and Contacts
Emily Chew, MD Study Chair National Eye Institute (NEI)
Overall Contact: Osnat Ehrman, MSc 952-334-5797 firstname.lastname@example.org