The Moran AMD Genetic Testing Assessment Study

Age-Related Macular Degeneration Clinical Trial

— MAGENTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265624
• Other study ID #: 150093
• Status: Recruiting
• Phase: Phase 2
• Start date: August 3, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: May 2023
• Source: University of Utah
• Contact: Lucia Lucci, MD, CCRC
• Phone: 801-585-6647
• Email: Lucia.Lucci[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Genetic Testing
• Macular Degeneration

Intervention

Behavioral:
• Early disclosure of genetic testing results
Early disclosure group receives results of genetic testing at Month 1
• Late disclosure of genetic testing results
Late disclosure group receives results of genetic testing at Month 12

Locations

Country	Name	City	State
United States	University of Utah John A. Moran Eye Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Paul S. Bernstein

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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