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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024424
• Other study ID #: IRB 60413
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 10, 2017

Study information

• Verified date: May 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Genetic Counseling
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Behavioral:
• Early disclosure

• Late disclosure

Locations

Country	Name	City	State
United States	University of Utah John A. Moran Eye Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

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