NCT00902785

Brief 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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
terminated

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

March 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

November 10, 2010

Status Verified

November 1, 2010

Enrollment Period

2.2 years

First QC Date

May 13, 2009

Last Update Submit

November 9, 2010

Conditions

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

Keywords

exploratoryobservationalnon-interventional study age-related macular degeneration (AMD) choroidal neovascularization (CNV)

Outcome Measures

Primary Outcomes (1)

  • Identify the sequence of change in the chorioretinal interface during the development of CNV and the progression from dry to neovascular AMD.

    2 years

Study Arms (1)

no drug

no drug

Other: no drug

Interventions

no drugOTHER

observational no drug

no drug

Eligibility Criteria

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

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Milan, 20157, Italy

Location

Pfizer Investigational Site

Coimbra, 3000-354, Portugal

Location

Pfizer Investigational Site

Belfast, BT12 6BA, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Choroidal NeovascularizationMacular Degeneration

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsRetinal DegenerationRetinal Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 15, 2009

Study Start

March 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

November 10, 2010

Record last verified: 2010-11

Locations

PT(1)GB(1)IT(1)