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Completed

NCT Number: NCT05265624

The Moran AMD Genetic Testing Assessment Study

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Genetic Testing Macular Degeneration Nutritional Biomarkers Retinal Degeneration Retinal Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early disclosure of genetic testing results

Behavioral

Early disclosure group receives results of genetic testing at Month 1

Late disclosure of genetic testing results

Behavioral

Late disclosure group receives results of genetic testing at Month 12

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Paul S. Bernstein

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Acronym: MAGENTA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2022
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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