Age-Related Macular Degeneration Clinical Trial
Official title:
Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
NCT number | NCT03024424 |
Other study ID # | IRB 60413 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | August 10, 2017 |
Verified date | May 2023 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goals of this study are: To assess the impact of genetic testing based on how it alters behaviors, to assess the utility of serum biomarker measurement in combination with genetic testing, to assess the utility of genetic counseling in personal analysis of risk for age-related macular degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal neovascularization (CNV).
Status | Completed |
Enrollment | 16 |
Est. completion date | August 10, 2017 |
Est. primary completion date | August 10, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - Caucasian (this particular genetic test is only validated in Caucasians) Participants can have a positive family history of AMD but this is not necessary. Exclusion Criteria: - Individuals with a personal history of AMD are not eligible. Non-caucasian individuals are not eligible. Employees of the Moran Eye Center are not eligible. - Individuals with a personal history of previous AMD genetic risk testing are not eligible. - Individuals with a major psychiatric disorder |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah John A. Moran Eye Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in carotenoid levels in the skin | Carotenoid levels in the skin are measured non-invasively at baseline and again at 12 months. Carotenoid levels are a biomarker of fruit and vegetable intake. | Twelve months | |
Primary | Change in carotenoid levels in the eyes | Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months. | Twelve months |
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