Treatment Exit Options for Non-infectious Uveitis (TOFU): Study Protocol for a Prospective Clinical Registry

ABSTRACT

Purpose

Currently, there is limited evidence regarding clinical management of non-anterior non-infectious uveitis including treatment outcomes of disease-modifying anti-rheumatic drugs (DMARDs) and their combinations. Treatment guidelines or recommendations on preferred choice of DMARD combinations and reduction and/or discontinuation strategies in quiescent uveitis are lacking. The TOFU (Treatment exit options for non-infectious uveitis) registry aims to document disease courses and to provide recommendations on DMARD treatment exit strategies.

Methods

The registry is an observational, non-commercial, and non-interventional study and targets patients who are ≥18 years of age with non-infectious uveitis of the posterior segment or retinal vasculitis on or starting DMARD treatment. Data are entered prospectively at study sites through a web-based interface into electronic case report forms (eCRF) implemented in the electronic data capture software RedCap (Version 9, Vanderbilt University, USA). The collated data include ophthalmological, general medical history and patient-reported outcomes (PROs). Assessment of uveitis classification and activity follows the international Standardization of uveitis nomenclature (SUN) criteria. Patient appointment and treatment decisions remain at the discretion of the managing physician and are completely independent of participation in the registry. The study follows the tenets of the declaration of Helsinki.

Conclusions

The TOFU registry captures real-life data of patients with non-infectious uveitis of the posterior segment, involving both medical personnel and patients. The study adheres to international standards and will provide important evidence and guidance in the development of guidelines.

KEYWORDS:

• Uveitis
• registry
• immunomodulatory treatment

Acknowledgments

We would like to thank the DUAG e.V. and Uveitis e.V. for their tremendous support in realizing the member surveys for the patient module.

Conflicts of interest

CH is a consultant for Alimera Sciences (Aldershot, Hampshire, UK) and received Honoria from AbbVie and Novartis.

RF is a consultant for Novartis, Allergan and Alimera Sciences and has received research funding by Novartis.

None of the following authors have any proprietary interests or conflicts of interest related to this submission: JQL, JD, MS

Contributions

The recommendations of the International Committee of Medical Journal Editors (ICMJE) were followed for all authors of this article. The authors read and approved the final manuscript.

This submission has not been published anywhere previously and that it is not simultaneously being considered for any other publication.

Database registration

Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF.de), Modellhafte Register – Realisierungsphase: 01GY1903; Deutsches Netzwerk für Versorgungsforschung (DNVF.de), AG Register: 01GY1903; German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS.de): DRKS00020382

TOFU registry study group (alphabetical order)

Gerd U. Auffarth, Nil Celik, Jennifer Dell, Christoph M. E. Deuter, Yassin Djalali-Talab, Deshka Doycheva, Katrin Engelmann, Nicole Eter, Nicolas Feltgen, Robert P. Finger, Rafael Grajewski, Rainer Guthoff, Arnd Heiligenhaus, Carsten Heinz, Frank G. Holz, Kai Januschowski, Jeany Q. Li, Thomas Neß, Uwe Pleyer, Mathias Roth, Dorothee Schwabe, Nicole Stübiger, Ioana Tarau, Stephan Thurau, Manfred Zierhut

Additional information

Funding

The TOFU registry is funded by the BMBF (Bundesministerium für Bildung und Forschung, German Federal Ministry of Education and Research; funding reference: 01 GY 1903) and the Stiftung Auge of the DOG (Deutsche Ophthalmologische Gesellschaft, German Ophthalmological Society). The pilot projects were funded by Retina.net (imaging module) and the DOG (patient module).