Home Vision Monitoring in Age-Related Eye Disease 2 (AREDS2) Using the ForeseeHome Device - Full Text View

Sponsor:	Notal Vision Ltd
Information provided by (Responsible Party):	Notal Vision Ltd
ClinicalTrials.gov Identifier:	NCT01103505

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
Age Related Macular Degeneration

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Home Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Eye Diseases Macular Degeneration

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 and after 12 months of treatment with an intravitreal anti-VEGF agent using either ranibizumab or bevacizumab when compared with standard care

Estimated Enrollment:	1000
Study Start Date:	May 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.
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
Sampling Method:	Probability Sample

Study Population

AREDS2 participants

Criteria

Inclusion Criteria:

Participants will be enrolled over a 9 to 12-month period and must meet the following criteria:

Male or female Age-Related Eye Disease 2 (AREDS2) participant 55 years of age or older who is actively being followed in AREDS2 and is expected to continue until the end of AREDS2.
Participant must be English speaking and understand and sign the protocol's informed consent document.
Participant does not have advanced AMD (neovascular AMD or central geographic atrophy) in at least 1 eye. The eye(s) that does not have advanced AMD must have at least intermediate AMD and will be the study eye(s).
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 must have a working phone land line in the participant's main residence.
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. Participants may be contacted as part of the study
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 take the device with them if staying somewhere else other than their primary residence for 7 days or more.
Participant has some experience using a computer.

Exclusion Criteria:

The following are exclusion criteria for prospective study participants:

Participant has evidence of macular or retinal disorders other than AMD in the study eye(s).
Participant has known adverse reaction to fluorescein dye.
Participant is seen at the clinic more frequently than every 4 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103505

Contacts

Contact: Osnat Ehrman, MSc	952-334-5797	osnat@notalvision.com
Contact: The EMMES Corporation	301-251-1161	areds2@emmes.com

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
Other Study ID Numbers:	ForeseeHome AREDS2
Study First Received:	April 12, 2010
Last Updated:	February 2, 2012
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 May 23, 2012