CIRCL - Cologne Image Reading Center and Laboratory
In der Augenheilkunde spielen moderne bildgebende Verfahren eine immer wichtigere Rolle bei der Diagnose und den Behandlungsentscheidungen in der täglichen Routine sowie in der klinischen Forschung. Insbesondere OCT-Biomarker werden häufig als Endpunkte in klinischen Studien für chorioretinale Erkrankungen eingesetzt. Die Interpretation der Bildgebung ist anspruchsvoll und zeitaufwändig und erfordert ein hohes Maß an Expertise. Professionelle Reading Center bieten eine standardisierte und unabhängige Bildauswertung für klinische Studien an.
Das Cologne Image Reading Center and Laboratory (CIRCL) wurde 2008 unter der Leitung von Frau Prof. Dr. Sandra Liakopoulos gegründet. Das CIRCL bietet qualitative und quantitative Analysen multimodaler Bildgebungen, darunter Farbaufnahmen des Augenhintergrundes (CFP), Fundusautofluoreszenz (FAF), Nahinfrarot-Bildgebung (NIR), Fluoreszenzangiografie (FA), optische Kohärenztomografie (OCT) und OCT-Angiografie (OCT-A) zur Unterstützung klinischer Forschungsstudien mit Schwerpunkt auf altersbedingter Makuladegeneration (AMD) und diabetischer Retinopathie (DR). Alle Bilder werden von trainierten und zertifizierten Reading Center Gradern nach den neuesten internationalen Standards ausgewertet.
Zu den Schwerpunkten des CIRCL gehören die Bildanalyse für klinische Studien zum Nachweis der Sicherheit und Wirksamkeit potenzieller neuer Therapien sowie akademische Forschung, einschließlich der Validierung nicht-invasiver Bildgebungsverfahren, der Bewertung neuer Biomarker und der Phänotypisierung für epidemiologische Studien.
In den vergangenen Jahren hat das CIRCL als zentrales Reading Center für verschiedene nationale und internationale klinische Studien der Phasen II, III und IV sowie für Beobachtungsstudien gedient. Darüber hinaus arbeitet das CIRCL mit nationalen und internationalen Kooperationspartnern an akademischen Forschungsprojekten.
About CIRCL
In ophthalmology, modern imaging techniques are playing an increasingly important role in diagnostic and treatment decisions in daily clinical routine as well as in clinical research. Especially OCT biomarkers are frequently used as endpoints in clinical trials for chorioretinal diseases. Image interpretation is challenging and time-consuming and requires a high level of expertise. Therefore, professional reading centers provide standardized and independent image analysis for clinical trials.
The Cologne Image Reading Center and Laboratory (CIRCL) was established in 2008 under the direction of Sandra Liakopoulos, MD. CIRCL provides qualitative and quantitative imaging analysis including color fundus photography (CFP), fundus autofluorescence (FAF), near infrared (NIR) imaging, fluorescein angiography (FA), optical coherence tomography (OCT) and OCT angiography (OCT-A) to support clinical research studies focusing on age-related macular degeneration (AMD) and diabetic retinopathy (DR). All images are evaluated by trained and certified reading center graders according to the most recent international standards.
Focus of CIRCL is on image analysis for clinical trials to demonstrate safety and efficacy of potential new treatments, as well as academic research, including validation of non-invasive imaging techniques for ophthalmic diseases, evaluation of new imaging biomarkers, and phenotyping for epidemiological studies.
Over the past years, CIRCL has served as the central reading center for various national and international phase II, phase III and phase IV clinical trials as well as observational studies. In addition, CIRCL is involved in academic research in cooperation with national and international collaboration partners.
Team
Medical Director
Sandra Liakopoulos, Prof. Dr.
Deputy: Felix Bock, Prof. Dr. rer. nat
Quality Manager
Maren Piel
Ina Wegner, Dr. rer. nat
Project Manager
Maren Piel
Ina Wegner, Dr. rer. nat.
Data Manager
Aileen Berghold, M. Sc.
Maren Piel
Ina Wegner, Dr. rer. nat
Grader
Aileen Berghold, M. Sc.
Elvira Bjelopera, Dr.
Anna Lentzsch, Dr.
Ina Wegner, Dr. rer. nat.
IT Support
IT Department of the University of Cologne, ISO 27001 certified
Quality Policy
Quality Service
CIRCL provides analysis of imaging data including Fluorescein Angiography, Color Fundus Photography and Optical Coherence Tomography for clinical trials under the highest quality standards according to Good Clinical Practice (GCP) and in compliance with currently valid national and international laws and regulations.
Quality Goals
The aim of quality management at CIRCL is to ensure that quality-related processes, regulations and procedures are in place in order to meet the requirements of our customers, cooperation partners, suppliers and employees.
Together with the sponsor, CIRCL ensures compliance with the points below:
- minimizing risks and burdens to the safety of study participants
- the highest possible data integrity
- the continuous improvement of processes at CIRCL
We achieve the quality goals by establishing, implementing and maintaining a documented effective quality management system.
Quality Policy
The following principles of action and guidance are applied at CIRCL:
- continuous training of CIRCL staff
- continuous improvement of processes and systems
- development and establishment of QM documents
- compliance with procedures, protocols, regulations, guidelines and laws
- regular review and renewal of this quality policy
- open communication within our team
- promoting an open error culture with solution-oriented feedback
- application of a risk-based approach
- quality control review of data reports prior to release
- two-grader system according to international standards
- CIRCL principal investigator review of cases in the grading workflow
National and International Cooperations
Classification of Atrophy Meeting Group (CAM)
Reading Center M3 Macula Monitor Münster
Reading Center GRADE Bonn
Utah Retinal Reading Center (UREAD)