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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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ClinicalTrials.gov Identifier: NCT03024424
Recruitment Status : Suspended
First Posted : January 18, 2017
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Paul S. Bernstein, 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).


Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Choroidal Neovascularization Genetic Counseling Behavioral: Early disclosure Behavioral: Late disclosure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Masking is applicable to risk of age-related macular degeneration, not to intervention assignment.
Primary Purpose: Prevention
Official Title: Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
Actual Study Start Date : March 2016
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024424


Locations
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United States, Utah
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Paul S. Bernstein, MD, PhD University of Utah Moran Eye Center
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Responsible Party: Paul S. Bernstein, Professor, Ophthalmology/Visual Sciences, University of Utah
ClinicalTrials.gov Identifier: NCT03024424    
Other Study ID Numbers: IRB 60413
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases