Age-Related Macular Degeneration Clinical Trial
— MAGENTAOfficial title:
A Phase 2 Study of the Value of Pre-symptomatic Genetic Risk Assessment for Age-Related Macular Degeneration
Verified date | May 2024 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 76 |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah John A. Moran Eye Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Paul S. Bernstein |
United States,
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 |
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