Skip to main content

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