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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT01103505
First received: April 12, 2010
Last updated: May 26, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
 Device: ForeseeHome
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The HOME Study: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device - (HOme Monitoring of the Eye)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • Early detection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Treatment results [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Enrollment: 1520
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Device: ForeseeHome
No Intervention: Standard care (control) arm
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD.

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103505

  Show 38 Study Locations
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Study Chair: Emily Chew, MD National Eye Institute (NEI)
  More Information

Additional Information:
Sponsor Home Page  This link exits the ClinicalTrials.gov site
AREDS2 page  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT01103505     History of Changes
Obsolete Identifiers: NCT01314430
Other Study ID Numbers: ForeseeHome AREDS2
Study First Received: April 12, 2010
Last Updated: May 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Notal Vision Ltd:
AMD
CNV

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013