Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01103505
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT01103505
Study Brief:
Protocol Section:
NCT01103505