NCT01083147

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 23, 2010

Status Verified

September 1, 2010

Enrollment Period

5 months

First QC Date

March 7, 2010

Last Update Submit

September 22, 2010

Conditions

Age-Related Macular Degeneration

Keywords

Intermediate AMD

Outcome Measures

Primary Outcomes (1)

  • Subject compliance with Foresee HomeTM device

    6 months

Secondary Outcomes (1)

  • Assessment of the Telemedicine infrastructure

    6 months

Study Arms (1)

Dry AMD

subjects diagnosed as intermediate AMD in at least one eye

Device: FORESEE HOME

Interventions

FORESEE HOMEDEVICE

Home Monitoring

Dry AMD

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

intermediate AMD

You may qualify if:

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

You may not qualify if:

  • Subjects who failed to complete participation in ForeseeHome-US2 study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitreos retina center

Toms River, New Jersey, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Daniel Roth, MD

    Vitreos retina center - NJ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2010

First Posted

March 9, 2010

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

September 1, 2010

Last Updated

September 23, 2010

Record last verified: 2010-09

Locations

US(1)