ClinicalTrials.gg
CompletedNCT03024424Updated May 6, 2023

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

An interventional study of Early disclosure and Late disclosure in Age-Related Macular Degeneration, Choroidal Neovascularization and Genetic Counseling, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by University of Utah · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Mar 2016, registered Jan 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Age-Related Macular Degeneration
  • Choroidal Neovascularization
  • Genetic Counseling
03

In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's enrollment of 16 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralEarly disclosure
  • BehavioralLate disclosure
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Twelve months

  2. Change in carotenoid levels in the eyes

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

    Time frame: Twelve months

07

Study locations

1 site
  • University of Utah John A. Moran Eye Center
    Salt Lake City, Utah 84132, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03024424
Lead sponsor
University of Utah
Responsible party
Paul S. Bernstein (Professor, Ophthalmology/Visual Sciences, University of Utah) — Principal investigator
First posted
Jan 18, 2017
Start date
Mar 2016
Primary completion
Aug 10, 2017
Completion
Aug 10, 2017
Last update
May 6, 2023

Study contacts

Paul S. Bernstein, MD, PhD
principal investigator · University of Utah Moran Eye Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion