A Study Of Early Markers Of Choroidal Neovascularization

NCT00902785

Last updated date
Study Location
Pfizer Investigational Site
Milano, , 20157, Italy
Contact
1-800-718-1021

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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.

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Choroidal Neovascularization (CNV), Age-related Macular Degeneration (AMD), Early MarkersA Study Of Early Markers Of Choroidal Neovascularization
NCT00902785
  1. Milano,
  2. Coimbra,
  3. Belfast,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title A Study Of Early Markers Of Choroidal Neovascularization
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
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.
Detailed Description CNV in one eye and dry AMD in the other
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  • age-related macular degeneration (AMD)
  • choroidal neovascularization (CNV)
Condition
  • Choroidal Neovascularization (CNV)
  • Age-related Macular Degeneration (AMD)
  • Early Markers
Intervention Other: no drug
observational no drug
Study Groups/Cohorts no drug
no drug
Intervention: Other: no drug
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Estimated Enrollment
 (submitted: May 14, 2009)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy,   Portugal,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00902785
Other Study ID Numbers A9011051
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2010