NCT00359008

Brief Summary

The primary objective of this study is to assess the ability of the PHP \& HPHP to detect newly diagnosed non treated Chorodial neovascularization (CNV) lesion associate with advanced age related Macular Degeneration (AMD) and differentiate them from Early/intermediate/GA AMD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
336

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

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

July 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 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 30, 2006

Last Update Submit

January 10, 2008

Conditions

Age Related Macular Degeneration

Keywords

AMDCNVPHP

Study Arms (2)

1

Intermediate AMD

2

New untreated CNV subject

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 in all sites.

You may qualify if:

  • Patients with AMD related lesions:
  • Newly diagnosed (up to 6 months) non-treated CNV patients secondary to AMD in the study eye, or GA patients or Early and Intermediate AMD patients.
  • Age ³ 50 for AMD patients
  • VA with habitual correction in study eye 6/60 or better
  • Mental and physical ability to perform a PHP/HPHP test
  • Subject able and willing to sign consent form and participate in study
  • Subject is not participating in another study when conducting the test

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 by biomicroscopy, fundus photography, or fluorescein angiography in the study eye
  • Any non-macular related ocular surgery performed within 3 months prior to the study in the study eye
  • CNV patient inability to tolerate intravenous fluorescein angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ha'emek Hospital

Afula, 18101, Israel

Location

Related Publications (5)

  • Alster Y, Bressler NM, Bressler SB, Brimacombe JA, Crompton RM, Duh YJ, Gabel VP, Heier JS, Ip MS, Loewenstein A, Packo KH, Stur M, Toaff T; Preferential Hyperacuity Perimetry Research Group. Preferential Hyperacuity Perimeter (PreView PHP) for detecting choroidal neovascularization study. Ophthalmology. 2005 Oct;112(10):1758-65. doi: 10.1016/j.ophtha.2005.06.008.

    PMID: 16154198BACKGROUND

  • Goldstein M, Loewenstein A, Barak A, Pollack A, Bukelman A, Katz H, Springer A, Schachat AP, Bressler NM, Bressler SB, Cooney MJ, Alster Y, Rafaeli O, Malach R; Preferential Hyperacuity Perimeter Research Group. Results of a multicenter clinical trial to evaluate the preferential hyperacuity perimeter for detection of age-related macular degeneration. Retina. 2005 Apr-May;25(3):296-303. doi: 10.1097/00006982-200504000-00008.

    PMID: 15805906BACKGROUND

  • Bressler NM. Age-related macular degeneration is the leading cause of blindness.. JAMA. 2004 Apr 21;291(15):1900-1. doi: 10.1001/jama.291.15.1900. No abstract available.

    PMID: 15108691BACKGROUND

  • Bressler NM. Early detection and treatment of neovascular age-related macular degeneration. J Am Board Fam Pract. 2002 Mar-Apr;15(2):142-52.

    PMID: 12002198BACKGROUND

  • Enoch JM, Williams RA, Essock EA, Barricks M. Hyperacuity perimetry. Assessment of macular function through ocular opacities. Arch Ophthalmol. 1984 Aug;102(8):1164-8. doi: 10.1001/archopht.1984.01040030942019.

    PMID: 6466179BACKGROUND

Related Links

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 30, 2006

First Posted

August 1, 2006

Study Start

July 1, 2006

Study Completion

September 1, 2007

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

IL(1)