About EU-ROP

We are fortunate that ROP requiring treatment is rare in Europe. Most hospitals in Germany for example treat only 3 to 5 children per year. The fact that only few infants need treatment for ROP makes it difficult for individual physicians to scientifically evaluate their data and draw conclusions for their daily practice. In 2011, the German Retina.net ROP Registry was established to provide a basis for joint data analysis across different German treatment centers. This registry has been active since 2012 and has collected data from over 300 treated ROP patients from 19 centers in Germany. Analyzing this data has already provided valuable information on treatment patterns, for example by identifying a considerable switch in treatment from laser coagulation to anti-VEGF agents over the recent years. These results were published in scientific journals and had an impact on the revised German guidelines on screening and treatment for ROP.

While the described findings from the German Retina.net ROP registry may be representative for the treatment patterns and outcomes in Germany, ROP patterns and disease progression are different in other countries. ROP is a disease that is very susceptible to subtle differences in neonatal and ophthalmological management. We know for example that ROP screening patterns, treatment approaches and neonatal care differ between countries within Europe. In order to obtain real-life data that is representative beyond one single country and to directly compare the different approaches, it is important to collect ROP treatment data in a multinational project. The EU-ROP project was initiated to achieve this goal.

We hope that many clinics from many countries will join the EU-ROP registry and enter their data. Joint analyses will make demographic parameters of patients needing treatment for ROP, the different treatment patterns, follow-up and outcome data available and comparable between participating European countries and centers.

The EU-ROP project builds on experience from the German Retina.net ROP registry. Therefore, at the beginning of this project there will be a selection bias for hospitals located in Germany, simply based on the history of the German registry. We hope to motivate many centers from various countries to participate and dilute our initial selection bias by building a strong and international foundation for EU-ROP. If you are a physician or clinical care manager involved in treating ROP infants and interested in joining the EU-ROP project, please have a look at the ”How to participate” section for contact information.

The following Ophthalmological and Neonatological societies as well as parent organisations support the EU-ROP project:

The EU-ROP project is currently financed by extramural grants from the University Medicine Greifswald, solicited through the EU-ROP principal investigator from Novartis Pharma AG and Bayer.

Companies supporting the registry do not have any influence on the content or the design of the registry.

All data documented in the EU-ROP registry is stored in a secured University-based server in Germany at the center for clinical trials Cologne. All appropriate measures to ensure the confidentiality of stored personal and health information will be implemented through pseudonymization and encryption. The EU-ROP registry adheres to the strict GDPR criteria set up by the European Union. The registry is registered at DRKS (DRKS00025138) and clinical trials.gov (Clinicaltrials.gov ID: NCT04939571)