The Natural History of Geographic Atrophy Progression (GAP) Study

This study has been terminated.

First Received on January 13, 2008. Last Updated on February 26, 2010 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00599846

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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

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):

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. Print 2011 Aug.

Schmitz-Valckenberg S, Fleckenstein M, Göbel 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. Print 2011.

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 February 09, 2012