Das klinische Ergebnis eines Therapiewechsels von Ranibizumab und/oder Bevacizumab zu Aflibercept bei neovaskulärer altersabhängiger Makuladegeneration (AMD)

Zusammenfassung

Hintergrund: Bei der Studie handelt es sich um eine retrospektive Auswertung des klinischen Effekts eines Therapiewechsels zu Aflibercept in Patienten mit neovaskulärer altersabhängiger Makuladegeneration (AMD), welche zuvor mangelndes Ansprechen auf eine Therapie mit Ranibizumab und/oder Bevacizumab aufwiesen. Patienten und Methoden: In die Studie wurden 96 Augen mit neovaskulärer altersabhängiger Makuladegeneration (AMD) eingeschlossen, die mit Ranibizumab und/oder Bevacizumab (T&E, Treat and Extend) vorbehandelt wurden und ein mangelndes Ansprechen auf die Therapie zeigten. Als mangelndes Ansprechen wurde hierbei ein rezidivbedingtes Injektionsintervall von < 6 Wochen definiert oder dauerhaft persistierende intra- und/oder subretinale Flüssigkeit oder persistierende Pigmentepithelabhebungen (PED). Die Patienten wurden für 12 Monate nach Therapieumstellung nachverfolgt. Die Veränderung der zentralen Netzhautdicke (CRT) wurde als primärer Endpunkt definiert. Weitere Endpunkte waren die axiale Höhe von PEDs und das Injektionsintervall. Ergebnisse: Als primärer Endpunkt zeigte sich eine signifikante Abnahme der durchschnittlichen CRT 12 Monate nach Therapieumstellung auf Aflibercept (− 31,36 µm; SD ± 70,64 µm; p < 0,001; Wilcoxon-Nemenyi-McDonald-Thompson-post-hoc-Test). Als weiterer morphologischer Endpunkt zeigte sich eine signifikante Verringerung der durchschnittlichen axialen PED-Höhe (− 34,10 µm; SD ± 91,90 µm; p < 0,001) von 207,82 µm (SD ± 148,12 µm) auf 173,72 µm (SD ± 132,30 µm). Gleichzeitig verlängerte sich das durchschnittliche Injektionsintervall signifikant (p < 0,001; Friedman-Test) von 1,30 Monaten (SD ± 0,19 Monate) vor Therapiewechsel auf 1,67 Monate (SD ± 0,19 Monate) nach 12 Monaten. Der bestkorrigierte Visus (BCVA) als funktioneller Endpunkt hat sich hingegen durch die Therapieumstellung auf Aflibercept nach 12 Monaten (+ 0,36 ETDRS-Buchstaben; SD ± 16,94 ETDRS-Buchstaben; p = 0,0972) nicht signifikant verbessert. Schlussfolgerung: Bei Patienten mit neovaskulärer AMD, die zunächst ein ungenügendes Ansprechen auf Ranibizumab und/oder Bevacizumab aufweisen, zeigt sich ein klinischer Nutzen durch eine Therapieumstellung auf Aflibercept. Neben morphologischen Verbesserungen, wie der Abnahme der CRT und der Höhe von PEDs, ließ sich eine Verlängerung des durchschnittlichen Injektionsintervalls beobachten. Eine Verbesserung des Visus zeigt sich auch nach 1 Jahr hingegen nicht.

Abstract

Background: The presented study is a retrospective evaluation of switching therapy from ranibizumab and/or bevacizumab to aflibercept in neovascular age-related macular degeneration in patients who had previously given an insufficient response to therapy with ranibizumab and/or bevacizumab. Patients and Methods: 96 eyes with neovascular age-related macular degeneration (AMD) were included, which had been pretreated with ranibizumab and/or bevacizumab (T&E), but had responded insufficiently. An injection interval of less than six weeks or permanently persisting intra- and/or subretinal fluid or persistent pigment epithelial detachments (PED) were defined as an insufficient response. The patients were followed for 12 months after switching therapy to aflibercept. The change in central retinal thickness (CRT) was defined as the primary endpoint. Other endpoints were the axial height of PEDs and the injection interval. Results: The primary endpoint, the average CRT, was significantly decreased twelve months after switching therapy to aflibercept (Wilcoxon Nemenyi-McDonald-Thompson post-hoc analysis − 31.36 µm; SD ± 70.64 µm; p < 0.001). Another morphological endpoint, the average axial height of PEDs, also decreased significantly (− 34.10 µm; SD ± 91.90 µm, p < 0.001) from 207.82 µm (SD ± 148.12 µm) at baseline to 173.72 µm (SD ± 132.30 µm) at month 12. Moreover, the average injection interval increased significantly (p < 0.001; Friedman test) from 1.30 months (SD ± 0.19 months) before switching therapy to 1.67 months (SD ± 0.19 months) at month 12 after switching therapy to aflibercept. However, the best corrected visual acuity (BCVA) as a functional endpoint did not significantly improve (+ 0.36 ETDRS letters = 0.0972 p; SD ± 16.94 ETDRS letters). Conclusion: In patients with neovascular AMD, who had initially exhibited an inadequate response to ranibizumab and/or bevacizumab, switching therapy to aflibercept improves clinical outcome measures. Besides morphological improvements, such as the decrease of the CRT and the axial height of PEDs, the average injection interval was prolonged. However, visual acuity did not improve.

Schlüsselwörter

Retina - Pharmakologie - Pathologie

Key words

retina - pharmacology - pathology

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