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The Natural History of Geographic Atrophy Progression (GAP) Study

This study has been terminated.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00599846
First received: January 13, 2008
Last updated: February 26, 2010
Last verified: February 2010
  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.


Condition
Age-Related Macular Degeneration
Geographic Atrophy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • GA progression rate using fundus autofluorescence [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GA progression rate using fundus photography [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2007
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients showing signs of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.

Exclusion Criteria:

  • Age related
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599846

Locations
United States, Texas
Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Patricia Zilliox Alcon Research
  More Information

No publications provided by Alcon Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patricia Zilliox, Alcon
ClinicalTrials.gov Identifier: NCT00599846     History of Changes
Other Study ID Numbers: C-06-30
Study First Received: January 13, 2008
Last Updated: February 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
age-related macular degeneration
geographic atrophy

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Macular Degeneration
Eye Diseases
Pathological Conditions, Anatomical
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014