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 |