The Moran AMD Genetic Testing Assessment Study (MAGENTA)

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: Recruiting
• Conditions: Age-Related Macular Degeneration; Genetic Testing; Nutritional Biomarkers
• Intervention / Treatment: Behavioral: Early disclosure of genetic testing results; Behavioral: Late disclosure of genetic testing results

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lucia Lucci, MD, CCRC; Phone Number: 801-585-6647; Email: Lucia.Lucci@hsc.utah.edu
• Study Contact Backup: Name: Paul Bernstein, MD, PhD; Phone Number: 801-581-4069; Email: Paul.Bernstein@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah John A. Moran Eye Center
      • Principal Investigator: Paul Bernstein, MD, PhD
      • Contact: Lucia Lucci, CCRC

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Reflectance Spectroscopy (RS) is measured by Veggie Meter 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	Resonance Raman Spectroscopy (RSS) is measured in Raman Units. 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	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 ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Density	Macular Pigment Optical Density (MPOD) is a unitless measure of the amount of carotenoids present in the macula. Possible scores range from 0 (no carotenoids detected) to greater than 1. Change = (Month 12 Score - Baseline Score).	Baseline and Month 12
Chang in serum carotenoid status in response to genetic risk disclosure	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

• Sponsor: Paul S. Bernstein

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): August 30, 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 (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 150093

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