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

NCT03024424 | Completed

• 1 other identifier: IRB 60413
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Age-Related Macular Degeneration; Choroidal Neovascularization; Genetic Counseling

Outcome Measures

Primary Outcomes (2)

• Change in carotenoid levels in the skin

  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

  Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months.

  Twelve months

Study Arms (2)

Early disclosure

EXPERIMENTAL

Early disclosure group receives results of genetic testing at Week 4

Behavioral: Early disclosure

Late disclosure

ACTIVE COMPARATOR

Late disclosure group receives results of genetic testing at final study visit (Month 12)

Behavioral: Late disclosure

Interventions

Early disclosure BEHAVIORAL

Early disclosure

Late disclosure BEHAVIORAL

Late disclosure

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian (this particular genetic test is only validated in Caucasians) Participants can have a positive family history of AMD but this is not necessary.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul S. Bernstein, MD, PhD

  University of Utah Moran Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking is applicable to risk of age-related macular degeneration, not to intervention assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ophthalmology/Visual Sciences

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 18, 2017
• Study Start: March 1, 2016
• Primary Completion: August 10, 2017
• Study Completion: August 10, 2017
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)