MISSION

The GRADE Reading Center provides innovative solutions for processing and analysis of imaging and other diagnostic data of the eye. The systematic and independent evaluation of these data plays a pivotal role to investigate efficacy and safety of new emerging therapeutic solutions in sight-threatening and blinding eye diseases.

Ophthalmology and in particular the area of retinal and macular diseases represent one of the most innovative medical disciplines. Research and development of new treatments demands to investigate innovative therapeutical interventions in well-designed clinical trials. Beyond subjective testing, high-resolution imaging has opened the door to assess and monitor retinal conditions with high accuracy, allowing to elucidate and to improve the understanding of the manifestation and progression of eye conditions as well as the response to treatments.
With easy access to patients and clinicians, imaging data can be acquired at multiple timepoints throughout the course of the disease and clinical studies in individual subjects. In order to achieve high-quality results, GRADE is committed to harmonise the image acquisition and conduct of ancillary diagnostic tests at multiple clinical sites and operators around the globe as well as to provide an independent and systematic analysis of the obtained data.

In this context, GRADE’s multidisciplinary team addresses the challenges of handling large amounts of data and to establish new diagnostic modalities. GRADE aims to develop, test and validate new and reliable clinical outcome measures for various eye diseases, including age-related macular degeneration (AMD). GRADE’s mission is to provide comprehensive reading center services, driven by scientific expertise and from the academic perspective, meeting highest standards and regulatory requirements for clinical research.

With all our efforts, we strive to contribute to avoiding preventable blindness from eye diseases in the future.

SERVICE

SOP for retinal imaging
acquisition and
functional assessment

Certification of imaging systems
and photographers at
clinical sites

Study design
and analysis

DATA TRANSFER AND
STORAGE OF RETINA IMAGES
AND FUNCTIONAL TEST DATA

IMAGE ANALYSIS WITH
CUSTOMIZED, AUTOMATED
SOFTWARE

CLASSIFICATION OF
DISEASE MARKERS

We seek to expand our national and international collaborations with partners in industry and academia as well with other health care professionals and bodies.

ABOUT GRADE

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). Along with new emerging imaging technologies and the development of new therapeutic strategies, the GRADE Reading Center was founded in 2006. GRADE was involved in the design and conduct of the first large-scale randomized interventional Phase II study in geographic atrophy (Fenretinide study, Sirion Therapeutics, Inc.). Since then, GRADE has collaborated within various projects both with national and international partners, including pharmaceutical companies, international networks and other reading centers. In 2012, the organization of GRADE was 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 invivo 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, identication of both prognostic and predictive markers for disease progression, and monitoring of novel therapies.

While retinal imaging represents an important tool for the assessment of efficacy and safety of new therapeutic interventions, there is an additional unmet need for robust, reliable and meaningful tests that allow the direct assesment of functional impairment and that are also accepted by regulatory agencies, health technology assessment bodies, and payers. This also includes a better understanding about the impact of desease-specific morphological changes to measurable retinal sensitivity. In this context, GRADE's activities have been recently also focused on the more detailed structural-functional analysis using mesopic and scotopic fundus-controlled perimetry (also called microperimetry) in combination with high-resolution retinal imaging.

State-of-the-art clinical trials require standardized acquistion, 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 functional tests as well as their evaluation must be ensured. These challenging tasks are realized by the Steinbeis-Forschungszentrum GRADE Reading Center, located at the Department of Ophthalmology of the University of Bonn, Germany.