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

Age Related Macular Degeneration Clinical Trial

— AREDS  

Official title:

The HOME Study: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device - (HOme Monitoring of the Eye)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103505
• Other study ID #: ForeseeHome AREDS2
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2019
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

Other known NCT identifiers

• NCT01314430

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1520
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Diagnostic Test:
• ForeseeHome AMD Monitoring Device
Earlier detection of progression from intermediate dry age-related macular degeneration to CNV between routine eye exams through home diagnostic testing with the ForeseeHome AMD Monitoring device

Locations

Country	Name	City	State
United States	Emory Univ. Eye Center	Atlanta	Georgia
United States	Elman Retina Group, PA	Baltimore	Maryland
United States	Wilmer Eye Institute	Baltimore	Maryland
United States	Ophthalmic Cons. of Boston	Boston	Massachusetts
United States	Pennsylvania Retina Specialists, P.C.	Camp Hill	Pennsylvania
United States	Charlotte Eye Ear Nose and Throat Assoc	Charlotte	North Carolina
United States	Retina Group of Washington	Chevy Chase	Maryland
United States	Case Western Reserve Univ.	Cleveland	Ohio
United States	Retina Assoc. of Cleveland	Cleveland	Ohio
United States	Texas Retina Associates	Dallas	Texas
United States	Georgia Retina, P.C.	Decatur	Georgia
United States	Colorado Retina Assoc.	Denver	Colorado
United States	Kresge Eye Institute	Detroit	Michigan
United States	Duke Univ.	Durham	North Carolina
United States	Vision Research Foundation	Grand Rapids	Michigan
United States	Penn State M.S. Hershey Med Ctr	Hershey	Pennsylvania
United States	Retina Consult. of Houston	Houston	Texas
United States	Univ. of Florida Health Science Center	Jacksonville	Florida
United States	Shiley Eye Center - UCSD	La Jolla	California
United States	Delaware Valley Retina Associates	Lawrenceville	New Jersey
United States	Retina Associates of Kentucky	Lexington	Kentucky
United States	Jones Eye Institute - UAMS	Little Rock	Arkansas
United States	Loma Linda Univ.	Loma Linda	California
United States	Eldorado Retina Associates	Louisville	Colorado
United States	Texas Retina Associates	Lubbock	Texas
United States	Univ. of Wisconsin	Madison	Wisconsin
United States	Univ. of Tennessee HSC	Memphis	Tennessee
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Yale Univ. Eye Center	New Haven	Connecticut
United States	Scheie Eye Institute	Philadelphia	Pennsylvania
United States	UPMC Eye Center	Pittsburgh	Pennsylvania
United States	Vision Research Foundation	Royal Oak	Michigan
United States	Univ. of California, Davis	Sacramento	California
United States	John Moran Eye Center, Univ. of Utah	Salt Lake City	Utah
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Retina Research Foundation	Slingerlands	New York
United States	Vision Research Foundation	Traverse City	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization	Mean change in BCVA (logMAR letters) from baseline to the time of confirmed progression to CNV in the ForeseeHome device monitoring group compared to the standard care group.	2 years
Secondary	Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection	Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm	2 years
Secondary	Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV	Median lesion size (total lesion area) at time of confirmed progression to CNV as measured on fluorescein angiography (FA) will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm^2.	2 years
Secondary	Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV	Median lesion size (CNV area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm^2.	2 years
Secondary	Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV	Median lesion size (fluid area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm^2.	2 years

External Links

•   AREDS2 page
•   Sponsor Home Page