The Moran AMD Genetic Testing Assessment Study (MAGENTA)

September 10, 2025 updated by: Paul S. Bernstein

A Phase 2 Study of the Value of Pre-symptomatic Genetic Risk Assessment for Age-Related Macular Degeneration

The goals of this study are:

To assess the impact of genetic testing for Age-related Macular Degeneration (AMD) on lifestyle behaviors as measured by systemic and ocular carotenoid status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants must be between 18 and 64 years of age.
  • They must also be Caucasian as this genetic test is only validated in Caucasians.
  • They can have a positive family history of AMD but this is not necessary.

Exclusion Criteria:

  • Personal history of AMD
  • Non Caucasian
  • Employee of the Moran or other eye care practice (likely to have more knowledge about AMD than a layperson)
  • Personal history of prior genetic testing for AMD risk
  • Anticipated cataract surgery in the upcoming year (can affect Macular Pigment measurement)
  • Major psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Genetic Results Disclosure
Early disclosure group receives results of genetic testing at Month 1
Behavioral: Early disclosure of genetic testing results
Early disclosure group receives results of genetic testing at Month 1
Active Comparator: Late Genetic Results Disclosure
Late disclosure group receives results of genetic testing at Month 12
Behavioral: Late disclosure of genetic testing results
Late disclosure group receives results of genetic testing at Month 12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy
Time Frame: Baseline and Month 12
Reflectance Spectroscopy (RS) is measured by Reflection Units. Possible scores range from 0 (no carotenoids detected) to greater than 500. Change = (Month 12 Score - Baseline Score).
Baseline and Month 12
Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Resonance Raman Spectroscopy
Time Frame: Baseline and Month 12
Resonance Raman Spectroscopy (RSS) is measured in Resonance Raman Units (RRU). Possible scores range from 0 (no carotenoids detected) to greater than 100,000. Change = (Month 12 Score - Baseline Score).
Baseline and Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ocular Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Macular Pigment Optical Volume
Time Frame: Baseline and Month 12
Macular Pigment Optical Volume (MPOV) is a unitless measure of the amount of carotenoids present in the macula. Possible scores range from 0 (no carotenoids detected) to greater than 50,000. Change = (Month 12 Score - Baseline Score).
Baseline and Month 12
Change in Serum Carotenoid Status in Response to Genetic Risk Disclosure
Time Frame: Baseline and Month 12
Serum carotenoid levels are measured in nanograms per milliliter (ng/mL). Possible scores range from 0 (no carotenoids detected) to greater than 1,000. Change = (Month 12 Score - Baseline Score).
Baseline and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul S. Bernstein

Collaborators

National Eye Institute (NEI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2022

Primary Completion (Actual)

July 12, 2024

Study Completion (Actual)

July 12, 2024

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150093
  • 1R21EY033579 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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