Status:
COMPLETED
Genetic Study of Age-Related Macular Degeneration
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Brief Summary
This study will examine skin and blood cells for genetic changes related to the development of age-related macular degeneration, an eye disease that can significantly impair the ability to read, drive...
Detailed Description
Age-related macular degeneration (AMD) represents the most common cause of blindness in patients over the age of 50. While both hereditary and environmental factors appear to play a role in the pathog...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- INCLUSION CRITERIA 1 THROUGH 3 APPLY TO THE FIRST TWELVE PARTICIPANTS ENROLLED. INCLUSION CRITERIA 4 THROUGH 6 APPLY TO THE LAST 50 PARTICIPANTS ENROLLED.
- AMD Patients: Diagnosis of AMD defined by the presence of at least one druse greater than 125 microns in diameter (4 patients) or geographic atrophy in at least one eye or choroidal neovascularization with drusen of any size in at least one eye (4 patients). (AMD cases only)
- Age 60 years or older.
- Age-matched control patients, absence of drusen or no more than 5 drusen less than 63 microns, absence of other diagnostic criteria for AMD, and age 60 years or older. The distribution of ages in the control group will be as similar as possible to the distribution of ages in the disease groups (4 patients).
- AMD Patients: Diagnosis of AMD defined by the presence of at least one druse greater than 125 microns in diameter (10 patients), geographic atrophy (10 patients) and choroidal neovascularization with drusen of any size in at least one eye and/or disciform scar (20 patients). (AMD cases only) Presence of neovascularization and disciform scar formation will be verified by color photography.
- Age 50 years or older.
- Age-matched control patients: absence of drusen or no more than 5 drusen less than 63 microns, absence of other diagnostic criteria for AMD, and age 50 years or older. The distribution of ages in the control group.
- EXCLUSION CRITERIA:
- Patient age less than 50 years.
- Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases which have been present prior to the age of 50.
- Opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate stereo fundus photography.
- Medical problems which make consistent follow-up over the treatment period unlikely (e.g., stroke, severe MI, terminal carcinoma).
- Inability or inaccessibility to obtain dermal biopsy from the inner aspect of both arms due to previous trauma, underlying skin disorder which would preclude good wound healing, previous surgery of the arm or breast which could prevent good wound healing or induce other changes at the biopsy site.
Exclusion
Key Trial Info
Start Date :
April 14 2000
Trial Type :
OBSERVATIONAL
End Date :
September 19 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00357578
Start Date
April 14 2000
End Date
September 19 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892