Vergleich von intravitrealem Dexamethason-Implantat mit intravitrealem Ranibizumab als Erstbehandlung des Makulaödems bei retinalen venösen Gefäßverschlüssen

 

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Zusammenfassung

Hintergrund: Die vorliegende Arbeit untersucht den Vergleich der intravitrealen Therapie mit Dexamethason-Implantat (Ozurdex®, Gruppe 1) und Anti-VEGF-Injektion (Lucentis®, Gruppe 2) zur Behandlung des Makulaödems bei retinalen venösen Gefäßverschlüssen in einer retrospektiven, nicht randomisierten Fallserie. Material und Methoden: Gruppe 1 enthielt 60 Patienten (31 mit zentralem Venenverschluss [ZVV] und 29 mit Venenastverschluss [VAV]) und Gruppe 2 52 Patienten (27 mit ZVV und 25 mit VAV). Im Falle eines Rezidivs wurden beide Gruppen jeweils weiter behandelt. Präoperativ und monatlich wurden die bestkorrigierte Sehschärfe (BKSS) und der intraokulare Druck (IOD) bestimmt, die zentrale Netzhautdicke mittels SD-OCT (Spectralis, Heidelberg Engineering) erhoben sowie eine Biomikroskopie und Fundusfotodokumentation durchgeführt. Primärer klinischer Endpunkt war die Visusentwicklung 12 Monate nach der 1. intravitrealen Therapie, sekundäre Endpunkte waren die zentrale Netzhautdicke und die Sicherheit der Therapie. Ergebnisse: Nach 12 Monaten wurde in der Gruppe 1 bei den ZVV-Patienten ein Anstieg der BKSS (± Standardabweichung) von 8,4 (± 1,9) Buchstaben, bei den VAV-Patienten ein Gewinn von 10,7 (± 3,8) Buchstaben beobachtet. In Gruppe 2 zeigten die ZVV-Patienten eine Zunahme der BKSS von 6,9 (± 1,9) Buchstaben nach 12 Monaten im Vergleich zu 12,5 (± 3,7) Buchstaben bei den VAV-Patienten. In beiden Gruppen konnte eine signifikante Reduktion der zentralen Netzhautdicke erreicht werden. Der IOD zeigte in knapp der Hälfte aller Fälle in Gruppe 1 einen Anstieg über 5 mmHg, konnte aber durch konservative antiglaukomatöse Therapie in den Fällen mit einem IOD über 21 mmHg (obere Normgrenze) in der Behandlungsphase gut reguliert werden. Allerdings zeigte sich bereits nach 2-maliger Ozurdex-Injektion (Gruppe 1) in ca. 50 % der Fälle eine Progression einer Linsentrübung. Schlussfolgerung: Ein direkter Vergleich beider Therapiestrategien zeigt einen signifikanten Unterschied in der Wirkung auf das funktionelle Ergebnis. Im Trend führt eine Behandlung mit Ozurdex bei den ZVV, Lucentis bei den VAV zu einem etwas besseren Sehschärfenanstieg nach 12 Monaten. Unabhängig von den Ergebnissen muss für Ozurdex der Linsenstatus und das Alter des Patienten berücksichtigt werden.

Abstract

Purpose: The present study investigated the treatment effect of dexamethasone implant (Ozurdex®, group 1) and anti-VEGF injection (Lucentis®, group 2) in course of macular oedema due to retinal vein occlusion in a retrospective, non-randomised case series. Material and Methods: Group 1 comprised 60 patients (31 with CRVO and 29 with BRVO) and group 2 included 52 patients, 27 with CRVO and 25 with BRVO) and both groups were further treated in case of recurrence. Preoperative and in monthly intervals best corrected visual acuity (BCVA), central retinal thickness using SD-OCT (Spectralis, Heidelberg Engineering), intraocular pressure, biomicroscopy status and a fundus photo documentation (Optomap) were evaluated. The primary clinical endpoint was visual acuity 12 months after the first intravitreal therapy, while secondary endpoints included the central retinal thickness change and safety of therapy. Results: In group 1, an increase of BCVA (± standard deviation) of 8.4 (± 1.9) letters was observed in CRVO patients and a gain of 10.7 (± 3.8) letters in BRVO patients after 12 months, while in group 2, an increase of BCVA of 6.9 (± 1.9) letters (CRVO) compared to 12.5 (± 3.7) letters (BRVO) was observed after the same time span. In both groups a significant reduction in retinal thickness was achieved. An increase of intraocular pressure above 5 mmHg was observed in nearly half of the cases In group 1, but was well controlled by conservative antiglaucomatous therapy. We observed a progression of lens opacity in approximately 50 % of the cases in group 1. Conclusion: The treatment with Ozurdex compared to Lucentis appears to provide a trend towards a better although not significant visual acuity increase after 12 months in CRVO patients. A similar trend favouring anti-VEGF treatment with Lucentis was seen in patients with BRVO. However, the lens status and age of the patient should be taken into account when considering a treatment with Ozurdex.

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