Clinical trial NCT01103505: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device
Official title: The HOME Study: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device - (HOme Monitoring of the Eye)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Macular Degeneration
Keywords: AMD
CNV
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-14
Enrollment: 1520
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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:

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

Primary outcomes:
measure: Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
timeFrame: 2 years
Secondary outcomes:
measure: Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection
timeFrame: 2 years
measure: Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV
timeFrame: 2 years
measure: Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV
timeFrame: 2 years
measure: Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV
timeFrame: 2 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Jones Eye Institute - UAMS
state: Arkansas
city: La Jolla
country: United States
facility: Shiley Eye Center - UCSD
state: California
city: Loma Linda
country: United States
facility: Loma Linda Univ.
state: California
city: Sacramento
country: United States
facility: Univ. of California, Davis
state: California
city: Denver
country: United States
facility: Colorado Retina Assoc.
state: Colorado
city: Louisville
country: United States
facility: Eldorado Retina Associates
state: Colorado
city: New Haven
country: United States
facility: Yale Univ. Eye Center
state: Connecticut
city: Jacksonville
country: United States
facility: Univ. of Florida Health Science Center
state: Florida
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Univ. Eye Center
state: Georgia
city: Decatur
country: United States
facility: Georgia Retina, P.C.
state: Georgia
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Elman Retina Group, PA
state: Maryland
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
city: Chevy Chase
country: United States
facility: Retina Group of Washington
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Cons. of Boston
state: Massachusetts
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Vision Research Foundation
state: Michigan
city: Royal Oak
country: United States
facility: Vision Research Foundation
state: Michigan
city: Traverse City
country: United States
facility: Vision Research Foundation
state: Michigan
city: Lawrenceville
country: United States
facility: Delaware Valley Retina Associates
state: New Jersey
city: Slingerlands
country: United States
facility: Retina Research Foundation
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat Assoc
state: North Carolina
city: Durham
country: United States
facility: Duke Univ.
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve Univ.
state: Ohio
city: Cleveland
country: United States
facility: Retina Assoc. of Cleveland
state: Ohio
city: Camp Hill
country: United States
facility: Pennsylvania Retina Specialists, P.C.
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State M.S. Hershey Med Ctr
state: Pennsylvania
city: Philadelphia
country: United States
facility: Scheie Eye Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
city: Memphis
country: United States
facility: Univ. of Tennessee HSC
state: Tennessee
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consult. of Houston
state: Texas
city: Lubbock
country: United States
facility: Texas Retina Associates
state: Texas
city: Salt Lake City
country: United States
facility: John Moran Eye Center, Univ. of Utah
state: Utah
city: Madison
country: United States
facility: Univ. of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: National Eye Institute (NEI)
name: Emily Chew, MD
role: STUDY_CHAIR
References: