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| Tracking Information | |||||
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| First Received Date ICMJE | January 13, 2008 | ||||
| Last Updated Date | October 1, 2009 | ||||
| Start Date ICMJE | December 2007 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
GA progression rate using fundus autofluorescence [ Time Frame: From baseline ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00599846 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
GA progression rate using fundus photography [ Time Frame: From baseline ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Natural History of Geographic Atrophy Progression (GAP) Study | ||||
| Official Title ICMJE | |||||
| Brief Summary | The objective of the 18-month trial is to evaluate the natural history of geographic atrophy by assessing the rate of progression of the geographic atrophic lesion over time. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 55 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00599846 | ||||
| Responsible Party | Patricia Zilliox, Alcon | ||||
| Study ID Numbers ICMJE | C-06-30 | ||||
| Study Sponsor ICMJE | Alcon Research | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Alcon Research | ||||
| Verification Date | October 2009 | ||||
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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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