A Study Of Early Markers Of Choroidal Neovascularization

NCT ID: NCT00902785

Last Updated: 2010-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

CNV in one eye and dry AMD in the other

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Choroidal Neovascularization (CNV) Age-related Macular Degeneration (AMD) Early Markers

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

exploratory observational non-interventional study age-related macular degeneration (AMD) choroidal neovascularization (CNV)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

no drug

no drug

no drug

Intervention Type OTHER

observational no drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no drug

observational no drug

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Coimbra, , Portugal

Site Status

Pfizer Investigational Site

Belfast, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy Portugal United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A9011051

Identifier Type: -

Identifier Source: org_study_id