A Study Of Early Markers Of Choroidal Neovascularization

November 9, 2010 updated by: Pfizer

A Two-Year Exploratory, Observational, Non-Interventional Multicenter Study To Identify Early Markers Of Choroidal Neovascularization In Fellow Eyes Of Patients With Neovascular AMD In One Eye

Identify early markers of choroidal neovascularization (CNV) in the fellow eye of a patient with CNV in the other eye due to age-related macular degeneration with the expectation of being able to identify patients in need of intervention.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

CNV in one eye and dry AMD in the other

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20157
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000-354
        • Pfizer Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • age-related macular degeneration (AMD)
  • choroidal neovascularization (CNV)

Description

Inclusion Criteria:

  • Sub-, extra- or juxta-foveal choroidal neovascularization (CNV) or macular scar due to AMD in the non-study eye.
  • No CNV or geographic atrophy in the study eye.
  • Best corrected visual acuity in the study eye of greater than 20/40 or better than 70 ETDRS letters.
  • Sufficiently clear ocular media and adequate pupillary dilatation to permit good quality fundus imaging of the study eye.
  • Subjects of either sex, aged 50 years.
  • Evidence of a signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
  • Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures.

Exclusion Criteria:

  • Subjects presenting with any of the following will not be included in the study:
  • Evidence of manifest CNV by FA, color photography or ICG angiography in the study eye.
  • Any prior treatment for CNV to the study eye (excluding vitamins and AREDS formula).
  • Significant media opacities, including cataract, which might interfere with visual acuity assessments, or fundus imaging in the study eye. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 2 years.
  • Presence of other causes of choroidal neovascularization in the fellow eye, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
  • Any progressive eye disease other than AMD (eg, glaucoma, diabetic retinopathy) in the study eye.
  • Presence of subretinal hemorrhage, serous or hemorrhagic pigment epithelial detachments, subretinal fibrosis or pigment epithelial tears or rips in the study eye.
  • Any medical condition that would interfere with the patient's ability to complete the trial.
  • Concurrent enrollment in any other observational or interventional clinical study.
  • Any treatment with an ocular or systemic investigational agent in the past 60 days for any medical condition.
  • Known serious allergies to the dye used in fluorescein angiography or ICG.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no drug
Other: no drug
observational no drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify the sequence of change in the chorioretinal interface during the development of CNV and the progression from dry to neovascular AMD.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (ESTIMATE)

May 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9011051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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