- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00599846
The Natural History of Geographic Atrophy Progression (GAP) Study
February 26, 2010 updated by: Alcon Research
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.
Study Overview
Status
Terminated
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients showing signs of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.
Description
Inclusion Criteria:
- Clinical diagnosis of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.
Exclusion Criteria:
- Age related
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
GA progression rate using fundus autofluorescence
Time Frame: From baseline
|
From baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
GA progression rate using fundus photography
Time Frame: From baseline
|
From baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Patricia Zilliox, Alcon Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Steinberg JS, Auge J, Jaffe GJ, Fleckenstein M, Holz FG, Schmitz-Valckenberg S; GAP Study Group. Longitudinal analysis of reticular drusen associated with geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2013 Jun 10;54(6):4054-60. doi: 10.1167/iovs.12-11538.
- Mauschitz MM, Fonseca S, Chang P, Gobel AP, Fleckenstein M, Jaffe GJ, Holz FG, Schmitz-Valckenberg S; GAP Study Group. Topography of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2012 Jul 26;53(8):4932-9. doi: 10.1167/iovs.12-9711.
- Schmitz-Valckenberg S, Alten F, Steinberg JS, Jaffe GJ, Fleckenstein M, Mukesh BN, Hohman TC, Holz FG; Geographic Atrophy Progression (GAP) Study Group. Reticular drusen associated with geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Aug 24;52(9):5009-15. doi: 10.1167/iovs.11-7235.
- Schmitz-Valckenberg S, Fleckenstein M, Gobel AP, Hohman TC, Holz FG. Optical coherence tomography and autofluorescence findings in areas with geographic atrophy due to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Jan 5;52(1):1-6. doi: 10.1167/iovs.10-5619.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
January 13, 2008
First Submitted That Met QC Criteria
January 23, 2008
First Posted (Estimate)
January 24, 2008
Study Record Updates
Last Update Posted (Estimate)
March 2, 2010
Last Update Submitted That Met QC Criteria
February 26, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-06-30
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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