A Study Of Early Markers Of Choroidal Neovascularization

Age-related Macular Degeneration (AMD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00902785
• Other study ID #: A9011051
• Status: Terminated
• Phase: Phase 4
• First received: May 13, 2009
• Last updated: November 9, 2010
• Start date: March 2008
• Est. completion date: May 2010

Study information

• Verified date: November 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

CNV in one eye and dry AMD in the other

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• no drug
observational no drug

Locations

Country	Name	City	State
Italy	Pfizer Investigational Site	Milano
Portugal	Pfizer Investigational Site	Coimbra
United Kingdom	Pfizer Investigational Site	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Italy,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the sequence of change in the chorioretinal interface during the development of CNV and the progression from dry to neovascular AMD.		2 years	No

External Links

•   To obtain contact information for a study center near you, click here.