The Moran AMD Genetic Testing Assessment Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Age-Related Macular Degeneration, Genetic Testing, Nutritional Biomarkers

Intervention / Treatment
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* Behavioral: Early disclosure of genetic testing results
* Behavioral: Late disclosure of genetic testing results


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Genetic Results Disclosure<br>Early disclosure group receives results of genetic testing at Month 1 | Behavioral: Early disclosure of genetic testing results<br>* Early disclosure group receives results of genetic testing at Month 1<br>|
| Active Comparator: Late Genetic Results Disclosure<br>Late disclosure group receives results of genetic testing at Month 12 | Behavioral: Late disclosure of genetic testing results<br>* Late disclosure group receives results of genetic testing at Month 12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |