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Clinical Trials/NCT03024424
NCT03024424
Completed
Not Applicable

Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD

University of Utah1 site in 1 country16 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Age-Related Macular Degeneration
Sponsor
University of Utah
Enrollment
16
Locations
1
Primary Endpoint
Change in carotenoid levels in the skin
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
August 10, 2017
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul S. Bernstein

Professor, Ophthalmology/Visual Sciences

University of Utah

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in carotenoid levels in the skin

Time Frame: Twelve months

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.

Change in carotenoid levels in the eyes

Time Frame: Twelve months

Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months.

Study Sites (1)

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