HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device (AREDS)
|ClinicalTrials.gov Identifier: NCT01103505|
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : October 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Device: ForeseeHome||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1520 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2010|
|Primary Completion Date :||October 2013|
|Study Completion Date :||December 2013|
Experimental: Device monitoring arm
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.
No Intervention: Standard care (control) arm
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD.
- Early detection [ Time Frame: 2 years ]To investigate whether the strategy of the use of the ForeseeHome comprehensive solution is associated with earlier detection of progression to neovascular AMD, as manifested by presenting best corrected visual acuity (BCVA) at the time of CNV diagnosis, lesion characteristics (e.g. lesion size) or time to confirmed CNV diagnosis , compared with standard care (control).
- Treatment results [ Time Frame: 2 years ]To investigate whether the use of the ForeseeHome comprehensive solution is associated with a better visual acuity outcome after confirmed progression to CNV and following 3 consecutive months of treatment with an intravitreal anti-VEGF agent using either ranibizumab or bevacizumab when compared with standard care
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103505
Show 38 Study Locations
|Study Chair:||Emily Chew, MD||National Eye Institute (NEI)|