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Klinischer Einsatz eines intravitrealen Dexamethason-Implantats in der Behandlung des Makulaödems

Therapy of macular edema with an intravitreal dexamethasone implant

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Zusammenfassung

Problemstellung

Das Makulaödem ist die wesentliche Ursache für eine Visusverschlechterung nach Ast- und Zentralvenenverschlüssen (AVV, ZVV) oder bei der diabetischen Retinopathie (DRP). Die derzeitigen Therapieoptionen sind unbefriedigend oder noch nicht ausreichend untersucht. Steroide sind durch ihre gefäßabdichtenden Eigenschaften geeignet und intravitreale Injektionen (z. B. Triamcinolon) haben sich als erfolgversprechend erwiesen, müssen aber häufig wiederholt werden.

Methoden und/oder Patienten

Posurdex (Fa. Allergan) ist ein kleines biologisch abbaubares Polymer-Implantat (0,45 × 6,5 mm), das mittels Applikator über die Pars plana intravitreal injiziert wird, und über einen Zeitraum von 6 bis 12 Monaten wirksam sein soll (Dexamethason posterior segment drug delivery system, DEX PS DDS).

Ergebnisse

Eine in den USA durchgeführte erste klinische Studie der Phase 2 zeigte nach 3 Monaten eine dosisabhängige Visusverbesserung und eine Abnahme der Netzhautdicke im OCT. Eine signifikante Wirksamkeit wurde bei Makulaödemen nach AVV, ZVV, DRP, Uveitis und nach Kataraktoperation gezeigt. An Komplikationen traten Augendruckanstiege und Glaskörperblutungen auf.

Schlussfolgerungen

Eine langdauernde kontrollierte intravitreale Steroidwirkung stellt eine therapeutische Hoffnung für die Therapie des Makulaödems dar. Aus den ersten Ergebnissen kann auf eine sichere und effektive Anwendung geschlossen werden. Die klinische Bedeutung wird sich aus den Langzeitergebnissen ableiten lassen.

Summary

Purpose

Macular edema is the main cause for visual decline after branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO) or at diabetic retinopathy (DRP). Current therapeutic options are not yet satisfying. Intravitreal steroids (e. g. Triamcinolone acetate) are promising, but they have to be repeated often.

Methods and patients

Posurdex (Allergan, Inc.) is a small biodegradable polymer-implant (0.45 × 6.5 mm), also called “dexamethasone posterior segment drug delivery system” (DEX PS DDS) and injected at pars plana with an injector intravitreally where it should be active 6 to 12 months. A phase 2 randomized multicenterstudy for treatment of macular edema due to different causes including 306 eyes in 3 groups (350 μg dexamethason, n = 100, 750 μg dexamethason, n = 101, control group, n = 105) has been finished after 6 months.

Results

The first clinical trial showed dose dependent improvement of visual acuity and reduction of retinal thickness in OCT after 3 months of treatment. A significant potency could be observed at macular edema due to BRVO, CRVO, DRP, uveitis and after cataract surgery. Complications included rise of intraocular pressure and vitreal hemorrhage group. During observation period no other complications could be observed.

Conclusion

A prolonged controlled release of intravitreal steroids represents a promising therapeutic option for the treatment of macular edema. The first results of a phase 2 study represent a safe and effective treatment. Further evaluation is necessary to evaluate clinical feasibility and long term results.

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Authors and Affiliations

  1. Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Wien, Währinger Gürtel 18-20, 1090, Wien, Österreich

    M. Georgopoulos, S. Sacu, P. V. Vecsei, S. Michels, C. Kiss, C. Scholda & U. Schmidt-Erfurth

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  1. M. Georgopoulos
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  2. S. Sacu
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  3. P. V. Vecsei
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  4. S. Michels
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  5. C. Kiss
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  6. C. Scholda
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  7. U. Schmidt-Erfurth
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Correspondence to M. Georgopoulos.

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Georgopoulos, M., Sacu, S., Vecsei, P.V. et al. Klinischer Einsatz eines intravitrealen Dexamethason-Implantats in der Behandlung des Makulaödems. Spektrum Augeheilkd 20, 231–233 (2006). https://doi.org/10.1007/BF03163806

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