The Moran AMD Genetic Testing Assessment Study (MAGENTA)

Paul S. Bernstein

Status and phase: Completed; Phase 2

Conditions: Age-Related Macular Degeneration; Genetic Testing; Nutritional Biomarkers

Treatments: Behavioral: Early disclosure of genetic testing results; Behavioral: Late disclosure of genetic testing results

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05265624

1R21EY033579 (U.S. NIH Grant/Contract)

150093

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Early Genetic Results Disclosure

Experimental group

Description:

Early disclosure group receives results of genetic testing at Month 1

Treatment:

Behavioral: Early disclosure of genetic testing results

Late Genetic Results Disclosure

Active Comparator group

Description:

Late disclosure group receives results of genetic testing at Month 12

Treatment:

Behavioral: Late disclosure of genetic testing results