Trials · 3 authors, 3 centres
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This protocol describes a phase 2, double-masked randomized controlled trial testing whether pre-symptomatic disclosure of AMD genetic risk motivates healthier lifestyle changes reflected in carotenoid levels. The trial randomizes pre-symptomatic individuals to immediate versus deferred disclosure and follows them for 12 months.
The MAGENTA study is a phase 2, single-center, prospective, double-masked randomized controlled trial conducted at the John A. Moran Eye Center, University of Utah. Pre-symptomatic participants are randomized by a 3:1 allocation ratio to immediate versus deferred disclosure of AMD genetic risk results and followed for 12 months. The primary outcome evaluates change over 1 year in skin carotenoid status assessed by resonance Raman spectroscopy and reflectance spectroscopy in response to genetic risk disclosure. Secondary outcomes examine changes in ocular and serum carotenoid status measured by Heidelberg Spectralis autofluorescence imaging, fluorescence lifetime imaging ophthalmoscopy, and high-performance liquid chromatography. Exploratory analyses will correlate AMD risk alleles with baseline carotenoid status and FLIO patterns, and assess the impact of disclosure using standardized surveys including possible referral for psychological counseling. A stated limitation is that participants' visual performance will not be assessed because the study is designed to ascertain changes in systemic and ocular carotenoids as a biomarker of healthy lifestyle, and confounders such as sunlight exposure and physical activity may also influence carotenoid levels.
