NCT00358345

Brief Summary

The primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no CNV. This study secondary is to enhance NotalVision normative database.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 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, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

First QC Date

July 27, 2006

Last Update Submit

January 10, 2008

Conditions

Age Related Macular Degeneration

Keywords

AMD

Study Arms (2)

1

Intermediate AMD

2

Newly diagnosed CNV

Eligibility Criteria

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

At least 200 subjects with intermediate AMD in at least one (1) eye based on medical record review and/or clinical diagnosis and at least 200 subjects with neovascular AMD in at least one (1) eye.

You may qualify if:

  • Newly diagnosed (up yo 2 months) CNV OR Intermediate AMD
  • Age \>50 for AMD subjects
  • Age \>18 for Myopic subjects
  • VA 20/160 or better in the study eye
  • Mental and physical ability to performed a PHP test

You may not qualify if:

  • Evidence of macular disease other than AMD or high myopia in the study eye.
  • Previous surgical or laser treatment within the macular erea.
  • Concurrent intraocular drug therapy (within 30 days).
  • Present of any significant media opacity that preclude a clear veiw of the macula.
  • Any non macular related ocular surgery performed within 3 months prior to the study.
  • CNV subjects inability to tolerate intravenous fluorscien angiography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky medical center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Ofer Sharon, MD

    Notal Vision

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 31, 2006

Study Start

October 1, 2003

Study Completion

September 1, 2007

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

IL(1)