[The oregis IVOM registry-Introduction of a registry for the systematic documentation of representative IVOM treatment data from routine treatment of macular diseases in Germany].

BACKGROUND

Intravitreal operative medication injection (IVOM) treatment in routine clinical practice often fails to achieve the treatment outcomes demonstrated in clinical trials. In Germany, comprehensive and representative real-world data on IVOM treatment (IVT) for macular diseases are still lacking.

OBJECTIVE

Against this background the oregis IVOM registry was established as a subregistry of the national oregis registry. The aim is the standardized collection and analysis of the course of IVOM treatment in the clinical routine in Germany, to evaluate long-term outcomes and identify potential areas for optimizing patient care. In this way participating ophthalmological centers can make an active contribution to the evidence-based development of IVOM treatment.

MATERIAL AND

METHODS

The oregis IVOM registry is a prospective, noninterventional observational study. Medical routine care data of adult patients receiving IVOM treatment for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), retinal vein occlusion (RVO) or choroidal neovascularization (CNV) are collected. Data acquisition is performed via web-based remote data entry into an electronic database using REDCap. Registry structure, datasets and data collection parameters are aligned with the international Fight Retinal Blindness! registry.

CONCLUSION

The oregis IVOM registry provides, for the first time, a nationwide structured platform for the systematic collection and evaluation of real-world IVT data in Germany. It closes an important evidence gap in health services research for IVOM treatment in Germany and enables regional and international comparisons as well as analyses of treatment adherence and real-world care.