The value of pre-symptomatic genetic risk assessment for age-related macular degeneration: the Moran AMD Genetic Testing Assessment (MAGENTA) study—a study protocol for a randomized controlled trial - Trials

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The value of pre-symptomatic genetic risk assessment for age-related macular degeneration: the Moran AMD Genetic Testing Assessment (MAGENTA) study—a study protocol for a randomized controlled trial - Trials
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An article published in Trials discusses MAGENTA: a study to find if pre-symptomatic testing for age-related macular degeneration risk can lead to quantifiable long-term changes in behavior and lifestyle associated with its lower incidence later in life.

MAGENTA is a single-center study conducted at the John A. Moran Eye Center, the University of Utah, Salt Lake City, Utah, USA. Study subjects will be primarily recruited from clinics at the Moran Eye Center, satellite clinics, and the university community at large. All study visits will be at the Moran Eye Center.Participants must be between 18 and 64 years of age.Participants can have a positive family history of AMD.Have personal history of AMD or have had prior genetic testing for AMD risk.

Importantly, if there are any amendments to the approved protocol which may directly affect the subject’s decision to continue participation in the study, the ICF will be revised to integrate the changes to the protocol, and the participant will be required to endorse the IRB-approved amended ICF. The consent form will request participants’ authorization to disclose pertinent data to regulatory authorities and the IRB, as deemed appropriate by the research team. There will be no collection and storage of biological samples for ancillary studies in the MAGENTA trial.MAGENTA is a phase 2, single-center, prospective, randomized, controlled clinical trial comparing the effect of immediate versus deferred disclosure of AMD genetic risk on biomarkers of ocular and systemic carotenoid status.

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