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Rheopherese® bei altersbedingter Makuladegeneration

Rheopheresis® for age-related macular degeneration

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Zusammenfassung

Hintergrund

In Österreich wurde die Rheopherese bei nichtexsudativer altersbedingter Makuladegeneration (AMD) zur Aufnahme in den Leistungskatalog beantragt. Entscheidungen zur Aufnahme neuer medizinischer Leistungen in Kataloge zur Kostenerstattung werden zunehmend evidenzbasiert gefällt, d. h. es werden Übersichtsarbeiten mit einer Beurteilung der vorhandenen klinischen Studien und ihrer patientenrelevanten Ergebnisse hinzugezogen.

Material und Methoden

Eine systematische Literatursuche in 5 Datenbanken identifizierte 2 randomisierte klinische Studien. Diese wurden qualitätsbeurteilt, die Ergebnisse extrahiert und in einer Übersichtsarbeit zusammengefasst.

Ergebnisse

Die beiden Studien mit insgesamt 238 Patienten zeigen, dass derzeit kein wissenschaftlicher Nachweis für eine Wirksamkeit der Rheopherese bei AMD vorliegt, gemessen an Veränderungen der Sehschärfe und deren klinischer Relevanz. In der größeren Studie konnte kein Effekt, in der kleineren nur ein Effekt von fraglicher klinischer Relevanz festgestellt werden. Auch über eine exakte Indikationsstellung kann anhand dieser Studien keine Aussage gemacht werden.

Schlussfolgerung

Da es sich um ein experimentelles Verfahren handelt, wird derzeit von einer Aufnahme der Rheopherese in den Leistungskatalog abgeraten.

Abstract

Background

In Austria, Rheopheresis for non-exudative age-related macular degeneration (AMD) has been proposed for inclusion into the benefit catalogue. Decisions on the inclusion of new medical interventions in reimbursement schemes or benefit catalogues are increasingly based on systematic reviews of clinical studies and their patient-relevant results.

Material and methods

A systematic literature search in five databases identified two randomised clinical trials (RCTs). A systematic analysis of the evidence based on the critical appraisal of the RCTs was carried out.

Results

Both RCTs, having a total of 238 included patients, show that to date, evidence for the effectiveness of Rheopheresis for AMD is not available, and predictions for exact indications cannot be made. The bigger RCT showed no effect at all, and the smaller one showed a small effect with questionable clinical relevance.

Conclusion

Available clinical data suggest considering Rheopheresis an experimental intervention. Its inclusion in the benefit catalogue is not recommended.

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Authors and Affiliations

  1. Ludwig Boltzmann Institut für Health Technology Assessment, Garnisongasse 7/20, 1090, Wien, Österreich

    C. Wild, S. Mathis, B. Guba & G. Gartlehner

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  1. C. Wild
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  2. S. Mathis
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  3. B. Guba
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  4. G. Gartlehner
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Correspondence to C. Wild.

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Wild, C., Mathis, S., Guba, B. et al. Rheopherese® bei altersbedingter Makuladegeneration. Ophthalmologe 106, 127–132 (2009). https://doi.org/10.1007/s00347-008-1768-1

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  • DOI: https://doi.org/10.1007/s00347-008-1768-1

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