A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.
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Change in multifocal pupillographic objective perimetry (mfPOP) response delays
Timeframe: Baseline to 1 year
Change in area under the log contrast sensitivity function (AULCSF)
Timeframe: Baseline to 1 year
Change in electroretinography parameter
Timeframe: Baseline to 1 year
Change in reading performance
Timeframe: Baseline to 1 year
Change in visual field function
Timeframe: Baseline to 1 year
Change in diabetic retinopathy severity
Timeframe: Baseline to 1 year
Change in retinal vascular pathology
Timeframe: Baseline to 1 year
Change in retinal structure
Timeframe: Baseline to 1 year
Change in retinal microvascular parameter
Timeframe: Baseline to 1 year