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

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT03024424
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 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: Mar 1, 2016
• Actual Primary Completion Date: Aug 10, 2017
• Actual Study Completion Date: Aug 10, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah John A. Moran Eye Center	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• University of Utah

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul S. Bernstein, Professor, Ophthalmology/Visual Sciences, University of Utah
• ClinicalTrials.gov Identifier: NCT03024424
• Other Study ID Numbers: IRB 60413
• First Posted: Jan 18, 2017
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic

Study Results

No Results Posted as of Aug 12, 2022