Characterization of Early Markers of Choroidal Neovascularization (CNV-Markers)
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| First Received Date ICMJE | December 2, 2008 | ||||
| Last Updated Date | February 25, 2013 | ||||
| Start Date ICMJE | December 2005 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Wet AMD development in the study eye. [ Time Frame: --- ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00801541 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Characterization of Early Markers of Choroidal Neovascularization | ||||
| Official Title ICMJE | Characterization of Early Markers of Choroidal Neovascularization in Fellow Eyes of Patients With AMD and CNV in One Eye. (CNV-Markers) | ||||
| Brief Summary | 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). |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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. |
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| Condition ICMJE | Age-related Macular Degeneration | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | AMD
Patients with wet AMD in one eye and dry AMD in the other eye (study eye). |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | June 2013 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Portugal | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00801541 | ||||
| Other Study ID Numbers ICMJE | CNTM326_A9010002 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Association for Innovation and Biomedical Research on Light and Image | ||||
| Study Sponsor ICMJE | Association for Innovation and Biomedical Research on Light and Image | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Association for Innovation and Biomedical Research on Light and Image | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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