NCT01103505

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,520 (actual)
• Sponsor: Notal Vision Ltd. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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:

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2010-04-14
• Last updated: 2019-07-30
• Results posted: 2019-07-16

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated device study