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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Choroidal Neovascularization; Genetic Counseling; Age-Related Macular Degeneration

Treatments: Behavioral: Late disclosure; Behavioral: Early disclosure

Study type: Interventional

Funder types: Other

Identifiers

NCT03024424

IRB 60413

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

Early disclosure

Experimental group

Description:

Early disclosure group receives results of genetic testing at Week 4

Treatment:

Behavioral: Early disclosure

Late disclosure

Active Comparator group

Description:

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

Treatment:

Behavioral: Late disclosure