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A Study Of Early Markers Of Choroidal Neovascularization

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Milano, , 20157 Italy
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Choroidal Neovascularization (CNV), Age-related Macular Degeneration (AMD), Early Markers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00902785
Pfizer
Terminated
A Study Of Early Markers Of Choroidal Neovascularization

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A Study Of Early Markers Of Choroidal Neovascularization
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.
CNV in one eye and dry AMD in the other
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
  • age-related macular degeneration (AMD)
  • choroidal neovascularization (CNV)
  • Choroidal Neovascularization (CNV)
  • Age-related Macular Degeneration (AMD)
  • Early Markers
Other: no drug
observational no drug
no drug
no drug
Intervention: Other: no drug
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
May 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Portugal,   United Kingdom
 
 
NCT00902785
A9011051
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2010

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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