Expired Study
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Houston, Texas 77030


Purpose:

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.


Criteria:

Inclusion Criteria: - Clinical diagnosis of geographic atrophy secondary to age-related macular degeneration with no CNV lesion. Exclusion Criteria: - Age related


Study is Available At:


Original ID:

C-06-30


NCT ID:

NCT00599846


Secondary ID:


Study Acronym:


Brief Title:

The Natural History of Geographic Atrophy Progression (GAP) Study


Official Title:


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

55 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alcon Research


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

1000


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Patricia Zilliox
Study Director
Alcon Research

Study Dates

Start Date:December 2007
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:February 2010
Last Changed Date:February 26, 2010
First Received Date:January 13, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:GA progression rate using fundus autofluorescence
Time Frame:From baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:GA progression rate using fundus photography
Time Frame:From baseline
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Alcon Research

Samples and Retentions

Study Population: Patients showing signs of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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