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

Not Applicable

Completed

• Conditions: Age-Related Macular Degeneration; Choroidal Neovascularization; Genetic Counseling
• Interventions: Behavioral: Late disclosure; Behavioral: Early disclosure

• Registration Number: NCT03024424
• Lead Sponsor: University of Utah

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Primary Completion: 2017-08-10
• Study Completion: 2017-08-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late disclosure	Late disclosure	Late disclosure group receives results of genetic testing at final study visit (Month 12)
Early disclosure	Early disclosure	Early disclosure group receives results of genetic testing at Week 4

Primary Outcome Measures

Name	Time	Method
Change in carotenoid levels in the skin	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	Twelve months	Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months.

Trial Locations

Locations (1)

University of Utah John A. Moran Eye Center; 🇺🇸 Salt Lake City, Utah, United States