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
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:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 15, 2014