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Zuverlässigkeit und Sicherheit von intravitrealen Ozurdex-Injektionen

Die ZERO-Studie

Reliability and safety of intravitreal Ozurdex injections

The ZERO study

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Zusammenfassung

Hintergrund

Seit Juli 2010 ist Ozurdex® in Deutschland für die Behandlung des Makulaödems (MÖ) von venösen retinalen Gefäßverschlüssen (RVV) zugelassen. In dieser klinischen Fallserie sollen die klinischen Erfahrungen zu Komplikationen und Nebenwirkungen der intravitrealen Applikation von Dexamethason systematisch zusammengefasst und analysiert werden.

Patienten und Methoden

In einer retrospektiven, multizentrischen Studie an 10 Zentren wurden 342 Augen mit RVV mit intravitrealer Dexamethason-Therapie (Ozurdex®, Allergan) behandelt und über einen Zeitraum von 8 Monaten nachkontrolliert. Dabei wurden intra-, peri- und postoperative Besonderheiten und Komplikationen (wie z. B. Augeninnendruckanstieg, Luxation des Implantats) systematisch erfasst.

Ergebnisse

Infektionen, Endophthalmitiden oder perioperative Hypotonien traten ebenso wie intraoperative Linsenverletzungen oder Netzhautablösungen nicht auf. Tensioanstiege waren mit nahezu 20% die häufigste Komplikation. Bei 9% der Patienten stieg der Augeninnendruck um mehr als 10 mmHg zum Ausgangswert, bei 6 Patienten auf > 35 mmHg. Bei vorbekanntem Glaukom stieg der Augeninnendruck nicht signifikant häufiger an als bei Nicht-Glaukompatienten. Eine Progression der Linsentrübung führte in 4 Fällen zu einer Phakoemulsifikation. Zwei Transplantatdislokationen in die Vorderkammer erforderten eine operative Reposition in den Glaskörperraum. In 2 Fällen trat postinterventionell ein Makulaforamen auf.

Schlussfolgerung

Die Ozurdex-Therapie zeigt sich auch in der klinischen Routine als nebenwirkungsarmes Therapieverfahren. Als häufigste Nebenwirkung der Ozurdex-Implantation sind Tensioanstiege zu beobachten, die in der Regel aber keiner operativen Intervention bedurften. Vorsicht ist bei Patienten mit einer Vorderkammerlinse und Iridektomie geboten. Makulaforamina als seltene Komplikation könnten Folge der Glaskörpertraktion bei der Implantation sein. In der klinischen Routineanwendung von Ozurdex zeigt sich keine höhere Komplikationsrate als in den Zulassungsstudien.

Abstract

Background

Since July 2010 Ozurdex® is approved in Germany for treatment of macular edema from retinal vein occlusion (RVO). The objective of this observational study was a systemic summary and analysis of clinical experience regarding complications and side effects of intravitreal administration of dexamethasone.

Patients and methods

In a retrospective, multicenter study conducted at 10 centers, 342 eyes with RVO were treated with intravitreal dexamethasone (Ozurdex®, Allergan). After treatment the patients were followed-up over a period of 8 months and intraoperative, perioperative and postoperative complications, such as elevated intraocular pressure and dislocation of implants were systematically recorded.

Results

No infections, endophthalmitis, perioperative hypotension, intraoperative lens injuries or retinal detachment occurred. Elevated intraocular pressure was the most common complication accounting for nearly 20 %. In 9 % of patients the intraocular pressure increased by more than 10 mmHg compared to baseline and in 6 patients to > 35 mmHg. In cases of known glaucoma intraocular pressure elevation was not significantly more frequent compared to non-glaucoma patients. In four cases a progression of lens opacity led to phacoemulsification and two implant dislocations in the anterior chamber required surgical repositioning in the vitreous cavity. In two cases a postinterventional macular hole was observed.

Conclusions

In the clinical routine Ozurdex treatment has proven to be a therapy method with minimal side effects. In Ozurdex administration intraocular pressure elevation was observed as the most common side effect; however, this generally did not require surgical intervention. Caution is advised in patients with an anterior chamber lens and iridectomy. Macular holes as a rare complication might result from vitreous traction during the administration process. In summary, even in the clinical routine application of Ozurdex the complication rate was not higher than in registration studies.

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Interessenkonflikt

Der korrespondierende Autor gibt für sich und seine Koautoren an, dass kein Interessenkonflikt besteht.

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Authors and Affiliations

  1. Augenklinik Franziskushospital Münster, Münster, Deutschland

    K. Schmitz & G. Spital

  2. Augenklinik TU München, München, Deutschland

    M. Maier

  3. Klinik und Poliklinik für Augenheilkunde, Universität Münster, Münster, Deutschland

    C.R. Clemens

  4. Augenklinik Klinikum Ludwigshafen, Ludwigshafen, Deutschland

    F. Höhn

  5. Augenklinik Gertrauden-Krankenhaus Berlin, Berlin, Deutschland

    J. Wachtlin

  6. Universitätsaugenklinik Regensburg, Regensburg, Deutschland

    F. Lehmann

  7. Augenklinik Philipps Universität Marburg, Marburg, Deutschland

    T. Bertelmann &  C.H. Meyer FEBO

  8. Augenklinik Klinikum Dortmund, Dortmund, Deutschland

    K. Rüdiger

  9. Augenklinik Universität Göttingen, Göttingen, Deutschland

    M. Horn

  10. Augenklinik Universität Bonn, Bonn, Deutschland

    A. Bezatis &  C.H. Meyer FEBO

  11. Augenklinik, Pallas Klinik, Louis Giroud-Str. 20, 4600, Olten, Schweiz

    C.H. Meyer FEBO

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  1. K. Schmitz
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  2. M. Maier
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German Retinal Vein Occlusion Group

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Correspondence to C.H. Meyer FEBO.

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Dieser Beitrag wurde in Teilen auf der Deutschen Ophthalmologischen Gesellschaft (DOG) Berlin 2011 präsentiert.

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Schmitz, K., Maier, M., Clemens, C. et al. Zuverlässigkeit und Sicherheit von intravitrealen Ozurdex-Injektionen. Ophthalmologe 111, 44–52 (2014). https://doi.org/10.1007/s00347-012-2737-2

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