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

May 3, 2023 updated by: Paul S. Bernstein, University of Utah

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah John A. Moran Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early disclosure
Early disclosure group receives results of genetic testing at Week 4
Behavioral: Early disclosure
Active Comparator: Late disclosure
Late disclosure group receives results of genetic testing at final study visit (Month 12)
Behavioral: Late disclosure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Twelve months
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.
Twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Paul S. Bernstein, MD, PhD, University of Utah Moran Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

August 10, 2017

Study Completion (Actual)

August 10, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 60413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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