The Moran AMD Genetic Testing Assessment Study

NCT05265624 | Completed Phase 2 Results DMC

• 2 other identifiers: 1500931R21EY033579
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-Related Macular Degeneration; Genetic Testing; Nutritional Biomarkers

Outcome Measures

Primary Outcomes (2)

• Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy

  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

  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 Outcomes (2)

• Change in Ocular Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Macular Pigment Optical Volume

  Baseline and Month 12

• Change in Serum Carotenoid Status in Response to Genetic Risk Disclosure

  Baseline and Month 12

Study Arms (2)

Early Genetic Results Disclosure

EXPERIMENTAL

Early disclosure group receives results of genetic testing at Month 1

Behavioral: Early disclosure of genetic testing results

Late Genetic Results Disclosure

ACTIVE COMPARATOR

Late disclosure group receives results of genetic testing at Month 12

Behavioral: Late disclosure of genetic testing results

Interventions

Early disclosure of genetic testing results BEHAVIORAL

Early disclosure group receives results of genetic testing at Month 1

Early Genetic Results Disclosure

Late disclosure of genetic testing results BEHAVIORAL

Late disclosure group receives results of genetic testing at Month 12

Late Genetic Results Disclosure

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul S. Bernstein: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Addo EK, Hartnett ME, Bernstein PS. The value of pre-symptomatic genetic risk assessment for age-related macular degeneration: the Moran AMD Genetic Testing Assessment (MAGENTA) study-a study protocol for a randomized controlled trial. Trials. 2023 Jun 19;24(1):414. doi: 10.1186/s13063-023-07436-4.

  PMID: 37337222 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Limitations and Caveats

Our study population was mainly Caucasian because the genetic testing had been validated in this population. Due to logistical constraints, we could not undertake expanded measures of lifestyle modification and coaching, potential active nutritional interventions, or follow-up with individuals in the deferred disclosure group to determine any psychological impact.

Results Point of Contact

• Title: Paul Bernstein, Principal Investigator
• Organization: University of Utah Moran Eye Center

Paul.Bernstein@hsc.utah.edu

801-585-7231

Study Officials

• Paul Bernstein, MD, PhD

  University of Utah Moran Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be masked to their AMD risk until their disclosure. Outcomes assessor and investigator will be masked to treatment assignment until completion of study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Ophthalmology/Visual Sciences

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 3, 2022
• Study Start: August 3, 2022
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: October 1, 2025
• Results First Posted: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)