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The Moran AMD Genetic Testing Assessment Study (MAGENTA)

P

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

Identifiers

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

76 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

76 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

Trial contacts and locations

1

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Central trial contact

Paul Bernstein, MD, PhD; Lucia Lucci, MD, CCRC

Data sourced from clinicaltrials.gov

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