NCT01073592

Brief Summary

The Foresee Home is used in the recent years to detect age-related macular degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV). The Foresee Home demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV. The OCT may be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices. The Foresee Home can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Typical duration 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

August 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

3.4 years

First QC Date

February 22, 2010

Last Update Submit

May 16, 2013

Conditions

Keywords

HMPCNVAMDPHPHPHPFORESEE HOME

Outcome Measures

Primary Outcomes (1)

  • Size and location of lesions

    6 months

Study Arms (1)

CNV patiens

Eligibility Criteria

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

Subjects suspected to have CNV secondary to AMD in at least one eye

You may qualify if:

  • Capable and willing to sign a consent form and participate in the study
  • Subjects diagnosed with CNV
  • Did not perform more then 4 anti- VGEF injections
  • VA with habitual correction better then 6/45 in the study eye
  • Ability to understand instructions
  • Familiar with computer usage

You may not qualify if:

  • Evidence of macular disease other than AMD or glaucoma in the study eye
  • Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
  • Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Ruth Siegal, Prof.

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 23, 2010

Study Start

August 1, 2009

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

May 17, 2013

Record last verified: 2013-05

Locations