A Study Of Early Markers Of Choroidal Neovascularization
NCT00902785
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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.
- 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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| 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 |
| |||
| Condition |
| |||
| 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 | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | November 2010 | |||