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| Sponsors and Collaborators: |
Association for Innovation and Biomedical Research on Light and Image Pfizer |
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| Information provided by: | Association for Innovation and Biomedical Research on Light and Image |
| ClinicalTrials.gov Identifier: | NCT00801541 |
Purpose
To this study and identify the sequence of alterations occurring in the chorioretinal interface during progression of AMD from "dry" AMD to sight-threatening chorioretinal neovascularization (CNV).
| Condition |
|---|
|
Age-Related Macular Degeneration |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Characterization of Early Markers of Choroidal Neovascularization in Fellow Eyes of Patients With AMD and CNV in One Eye. Two-Year Follow-up. (CNV-Markers) |
| Enrollment: | 60 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
AMD
Patients with wet AMD in one eye and dry AMD in the other eye (study eye).
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The primary statistical objective of this study is to identify the sequence of alterations occurring in the chorioretinal interface during progression of AMD from risk "dry" AMD to sight-threatening chorioretinal neovascularization (CNV) (wet AMD).
Different imaging methods will be used simultaneously and at regular intervals in order to characterize markers or predictors of conversion to sight-threatening CNV will be: CNV (classic or occult) or position of CNV within 2500 µm (~1.7 disc diameters) of the foveal center, as evidenced by fluorescein angiography. This is an institutional, prospective, observation study to be performed in fellow eyes of patients with evidence of "wet" AMD in other eye.
Therefore, patients will have evidence of exudative ("wet") AMD in one eye ( the non-study eye) and non-exudative ("dry") AMD in the fellow eye (the study eye) that is at risk for progressive to exudation "wet" CNV.
Patients will exit the study at the time of developing sight-threatening CNV in the study eye and will be treated at the discretion of the physician.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients of either sex, any race, aged over 50 years and over, diagnosed with exudative (wet) AMD in one eye (non-study eye) and non-exudative (dry) AMD (intermediate or large/confluent drusen, with hyperpigmentation, and no CNV or geographic atrophy) in the other eye (study eye) that is at risk for progressing to exudative (wet) AMD and meet all the inclusion and exclusion criteria.
Inclusion Criteria:
Clinical diagnosis of exudative AM;D in one eye (non-stud eye) and the presence of the following characteristics in the second eye (study eye, eye to be treated):
Exclusion Criteria:
Contacts and Locations| Portugal | |
| AIBILI - Clinical Trial Center | |
| Coimbra, Portugal, 3000-548 | |
| Principal Investigator: | José Cunha-Vaz, MD PhD | Association for Innovation and Biomedical Research on Light and Image |
More Information
| Responsible Party: | AIBILI ( José Cunha-Vaz, MD PhD ) |
| Study ID Numbers: | CNTM326_A9010002 |
| Study First Received: | December 2, 2008 |
| Last Updated: | April 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00801541 History of Changes |
| Health Authority: | Portugal: Health Ethic Committee |
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AMD |
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Metaplasia Eye Diseases Choroid Diseases Retinal Degeneration |
Macular Degeneration Neovascularization, Pathologic Retinal Diseases Choroidal Neovascularization |
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Uveal Diseases Pathologic Processes Metaplasia Eye Diseases Choroid Diseases |
Retinal Degeneration Macular Degeneration Neovascularization, Pathologic Retinal Diseases Choroidal Neovascularization |
