Introduction

The GRADE Reading Center was established to fulfil the increasing need of standardized and systematic analysis of digital retinal imaging for prospective clinical trials. This involves studies on the natural history of potentially blinding retinal diseases as well as interventional trials to evaluate the efficacy and safety of new therapeutic strategies.

The origin of GRADE goes back to the FAM (Fundus Autofluorescence in Age-related Macular Degeneration)-Study - a multicenter national history study on patients with geographic atrophy secondary to age-related macular degeneration. This project was initiated in 2000 and funded by the German Research Council (DFG). This project also included the development of automated image analyses strategies for investigation of quantitative endpoints.

The GRADE Reading Center was founded in 2006. GRADE was involved in the design and conduct of the first large-scale randomised interventional Phase II study in geographic atrophy (Fenretinide study, Sirion Therapeutics, Inc.), followed by other pharmaceutical trials in the recent years. By 2012, the organisation of GRADE has been transformed from a university research unit to a research center of the Steinbeis network.

New emerging imaging technologies such as confocal scanning laser ophthalmoscopy and spectral-domain optical coherence tomography provide new insights in the human retina in-vivo and give information above and beyond that obtained by conventional imaging methods. They also contribute to our understanding of pathophysiological mechanisms, diagnostics, phenotype-genotype correlation, identification of predictive markers for disease progression, and monitoring of novel therapies.

State-of-the-art clinical trials require standardized acquisition, processing and analysis of clinical data. National and international agencies demand internal validation of all applied procedures. Reproducibility and observer variability of new retinal imaging techniques and their evaluation must be ensured. These challenging tasks are realized by The GRADE Reading Center, located at the Department of Ophthalmology of the University of Bonn.

The collaboration with national and international partners plays a key role in the work of the GRADE Reading Center. These include other reading centers, pharmaceutical companies and international networks such as the EVICR.net (European Network of Clinical Research in Ophthalmology).