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Table 1 Objectives of the MACUSTAR study

From: Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention—MACUSTAR

  Cross-sectional part Longitudinal part
Primary objectives Technical evaluation of functional and structural candidate outcomes Assessment of prognostic power of functional, structural, and patient-reported outcomes for progression from iAMD to late AMD
Secondary objectives Correlation analyses between defined structural, functional, and patient-reported outcome measures;
Evaluation of discriminative ability of outcome measures (with respect to AMD stages and participants without AMD);
Implementation of a database for no AMD, early AMD, iAMD, and late AMD
Correlation analyses between defined structural, functional, and patient-reported outcome measures over time;
Evaluation of the natural history of iAMD biomarkers
Exploratory objectives Hypothesis-free testing of associations/correlations Identification of sub-stages of iAMD that relate to progression to late AMD;
Assessment of the association of single and combined endpoints to the final status of patients (progressed vs. not progressed);
Hypothesis-free testing of associations/correlations