Back to resultsValue of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
Primary Purpose
Age-Related Macular Degeneration, Choroidal Neovascularization, Genetic Counseling
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early disclosure
Late disclosure
Sponsored by
About this trial
This is an interventional prevention trial for Age-Related Macular Degeneration
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
Sites / Locations
- University of Utah John A. Moran Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early disclosure
Late disclosure
Arm Description
Early disclosure group receives results of genetic testing at Week 4
Late disclosure group receives results of genetic testing at final study visit (Month 12)
Outcomes
Primary Outcome Measures
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.
Change in carotenoid levels in the eyes
Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03024424
Brief Title
Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
Official Title
Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
August 10, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration, Choroidal Neovascularization, Genetic Counseling
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Masking is applicable to risk of age-related macular degeneration, not to intervention assignment.
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early disclosure
Arm Type
Experimental
Arm Description
Early disclosure group receives results of genetic testing at Week 4
Arm Title
Late disclosure
Arm Type
Active Comparator
Arm Description
Late disclosure group receives results of genetic testing at final study visit (Month 12)
Intervention Type
Behavioral
Intervention Name(s)
Early disclosure
Intervention Type
Behavioral
Intervention Name(s)
Late disclosure
Primary Outcome Measure Information:
Title
Change in carotenoid levels in the skin
Description
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.
Time Frame
Twelve months
Title
Change in carotenoid levels in the eyes
Description
Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months.
Time Frame
Twelve months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S. Bernstein, MD, PhD
Organizational Affiliation
University of Utah Moran Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah John A. Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
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