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The Moran AMD Genetic Testing Assessment Study (MAGENTA)

Primary Purpose

Age-Related Macular Degeneration, Genetic Testing, Nutritional Biomarkers

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Early disclosure of genetic testing results
Late disclosure of genetic testing results
Sponsored by
Paul S. Bernstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age-Related Macular Degeneration

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Utah John A. Moran Eye CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Genetic Results Disclosure

Late Genetic Results Disclosure

Arm Description

Early disclosure group receives results of genetic testing at Month 1

Late disclosure group receives results of genetic testing at Month 12

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
February 8, 2022
Last Updated
May 3, 2023
Sponsor
Paul S. Bernstein
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1. Study Identification

Unique Protocol Identification Number
NCT05265624
Brief Title
The Moran AMD Genetic Testing Assessment Study
Acronym
MAGENTA
Official Title
A Phase 2 Study of the Value of Pre-symptomatic Genetic Risk Assessment for Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul S. Bernstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration, Genetic Testing, Nutritional Biomarkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Genetic Results Disclosure
Arm Type
Experimental
Arm Description
Early disclosure group receives results of genetic testing at Month 1
Arm Title
Late Genetic Results Disclosure
Arm Type
Active Comparator
Arm Description
Late disclosure group receives results of genetic testing at Month 12
Intervention Type
Behavioral
Intervention Name(s)
Early disclosure of genetic testing results
Intervention Description
Early disclosure group receives results of genetic testing at Month 1
Intervention Type
Behavioral
Intervention Name(s)
Late disclosure of genetic testing results
Intervention Description
Late disclosure group receives results of genetic testing at Month 12
Primary Outcome Measure Information:
Title
Change in skin carotenoid status in response to genetic risk disclosure as measured by Reflectance Spectroscopy
Description
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).
Time Frame
Baseline and Month 12
Title
Change in skin carotenoid status in response to genetic risk disclosure as measured by Resonance Raman Spectroscopy
Description
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).
Time Frame
Baseline and Month 12
Secondary Outcome Measure Information:
Title
Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Volume
Description
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).
Time Frame
Baseline and Month 12
Title
Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Density
Description
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).
Time Frame
Baseline and Month 12
Title
Chang in serum carotenoid status in response to genetic risk disclosure
Description
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).
Time Frame
Baseline and Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Lucci, MD, CCRC
Phone
801-585-6647
Email
Lucia.Lucci@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Bernstein, MD, PhD
Phone
801-581-4069
Email
Paul.Bernstein@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Bernstein, MD, PhD
Organizational Affiliation
University of Utah Moran Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah John A. Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Lucci, CCRC
First Name & Middle Initial & Last Name & Degree
Paul Bernstein, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Moran AMD Genetic Testing Assessment Study

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