Age-Related Macular Degeneration (AMD) - Beta Study Telem... | NCT01083147

Studies
Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment

NCT01083147

Sponsor

Notal Vision Ltd.

Status

Completed

Last Update Posted

Sep 23, 2010Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Age-Related Macular Degeneration

Interventions

FORESEE HOME

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Mar 7, 2010

First Submission Date that Met QC Criteria

Mar 8, 2010

First Posted Date

Mar 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2010

Last Update Posted Date

Sep 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.

Detailed Description

This is a non-randomized cohort, multi-center study. The eligible subjects will be asked to use the FORESEE HOME device daily and the tests results will be automatically transmitted to the Data Monitor Center for analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dry AMD		subjects diagnosed as intermediate AMD in at least one eye	Device: FORESEE HOME

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FORESEE HOME	Device	Home Monitoring	Dry AMD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subject compliance with Foresee HomeTM device		6 months

Secondary Outcomes

Measure	Description	Time Frame
Assessment of the Telemedicine infrastructure		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who successfully completed participation in ForeseeHome-US2 study
Patients with ability to comprehend and sign the informed consent/authorization

Exclusion Criteria:

Subjects who failed to complete participation in ForeseeHome-US2 study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

intermediate AMD

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Roth, MD	Vitreos retina center - NJ	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vitreos retina center		Toms River	New Jersey		United States

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided