HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device
- Conditions
- Age Related Macular Degeneration
- Interventions
- Diagnostic Test: ForeseeHome AMD Monitoring Device
- Registration Number
- NCT01103505
- Lead Sponsor
- Notal Vision Ltd.
- 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:
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1520
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ForeseeHome AMD Monitoring Device ForeseeHome AMD Monitoring Device 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 in addition to standard care
- Primary Outcome Measures
Name Time Method Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization 2 years 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.
- Secondary Outcome Measures
Name Time Method Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV 2 years 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.
Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV 2 years 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.
Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection 2 years Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm
Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV 2 years 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.
Trial Locations
- Locations (35)
Jones Eye Institute - UAMS
🇺🇸Little Rock, Arkansas, United States
Shiley Eye Center - UCSD
🇺🇸La Jolla, California, United States
Loma Linda Univ.
🇺🇸Loma Linda, California, United States
Univ. of California, Davis
🇺🇸Sacramento, California, United States
Eldorado Retina Associates
🇺🇸Louisville, Colorado, United States
Yale Univ. Eye Center
🇺🇸New Haven, Connecticut, United States
Univ. of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Georgia Retina, P.C.
🇺🇸Decatur, Georgia, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Retina Group of Washington
🇺🇸Chevy Chase, Maryland, United States
Vision Research Foundation
🇺🇸Traverse City, Michigan, United States
Retina Research Foundation
🇺🇸Slingerlands, New York, United States
Delaware Valley Retina Associates
🇺🇸Lawrenceville, New Jersey, United States
Charlotte Eye Ear Nose and Throat Assoc
🇺🇸Charlotte, North Carolina, United States
Penn State M.S. Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Pennsylvania Retina Specialists, P.C.
🇺🇸Camp Hill, Pennsylvania, United States
Univ. of Tennessee HSC
🇺🇸Memphis, Tennessee, United States
Texas Retina Associates
🇺🇸Lubbock, Texas, United States
Univ. of Wisconsin
🇺🇸Madison, Wisconsin, United States
Colorado Retina Assoc.
🇺🇸Denver, Colorado, United States
Duke Univ.
🇺🇸Durham, North Carolina, United States
Case Western Reserve Univ.
🇺🇸Cleveland, Ohio, United States
Retina Assoc. of Cleveland
🇺🇸Cleveland, Ohio, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Elman Retina Group, PA
🇺🇸Baltimore, Maryland, United States
Emory Univ. Eye Center
🇺🇸Atlanta, Georgia, United States
Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Eye Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Wilmer Eye Institute
🇺🇸Baltimore, Maryland, United States
Ophthalmic Cons. of Boston
🇺🇸Boston, Massachusetts, United States
Retina Consult. of Houston
🇺🇸Houston, Texas, United States
John Moran Eye Center, Univ. of Utah
🇺🇸Salt Lake City, Utah, United States
Kresge Eye Institute
🇺🇸Detroit, Michigan, United States