Feasibility Studies for the Future Mediterranean Glucose Lowering Dietfor Vision Extension in AMD (M-GLOVE-AMD)

PROJECT SUMMARY Age related macular degeneration (AMD) is a leading cause of vision loss in individuals over 55-years of age and is increasing as the world population becomes older. Treatment options for early AMD are limited and, therefore, vision will become increasingly threatened in the elderly population. Evidence from observational

studies suggest that whole foods, Mediterranean diets and low glycemic load (LG) diets are associated with less progression of AMD, suggesting a cost-effective approach to slow AMD progression. The goal of this project is to assess feasibility aims for dietary intervention in a non-diabetic AMD cohort with early stage

disease and to plan a future large, multicenter study that will compare LG-Mediterranean dietary intervention to standard diet. Our aims are to: 1) demonstrate feasibility of behavioral intervention to change dietary intake in subjects with intermediate AMD from consuming a typical Western diet to a LG, Mediterranean diet; 2) assess

the feasibility of obtaining sensitive retinal images and sdOCTs and to explore assays (metabolomic markers, complement factors, gut barrier dysfunction and dysbiosis, AGEs, and oxycholesterols (e.g. 7-ketocholesterol) for consideration as non-disease biomarkers for a future UG1; 3) develop a protocol for a future multicenter

study and a Manual of Procedures. Our team is cross-disciplinary including experts in behavioral dietary intervention, endocrinologists, retinal specialists, clinical trial experts and leaders of large consortia of AMD intervention studies in the US and Europe. Innovative aspects of the planning study include: to assess the

willingness of an elderly population without diabetes to adopt a dietary intervention; to use continuous glucose monitoring as a coaching tool for the cohort and to learn about the sensitivity of continuous glucose monitoring for the future multicenter study; to explore ophthalmologic and non-ophthalmologic biomarkers for the future

study; and to perform feasibility studies on systemic biomarkers relevant to the pathophysiology of AMD and that may improve sensitivity of outcome measures in the future multicenter clinical trial.