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OpenTrials
Completed

NCT Number: NCT03024424

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

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).

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Key information

Conditions

Age-Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Genetic Counseling Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early disclosure

Behavioral

Late disclosure

Behavioral

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2017
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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