Aflibercept vs. Ranibizumab – funktionelle und morphologische Ergebnisse bei mit Ranibizumab vorbehandelter, chronisch-rezidivierender neovaskulärer altersabhängiger Makuladegeneration

Zusammenfassung

Hintergrund: Ein Vergleich der funktionellen und morphologischen Ergebnisse der Therapie mit Aflibercept oder Ranibizumab bei Patienten mit chronisch rezidivierender neovaskulärer altersabhängiger Makuladegeneration (nAMD) und Vorbehandlung mit Ranibizumab.

Patienten und Methoden: Retrospektive Analyse von Augen, die mit ≥ 3 Injektionen Ranibizumab vorbehandelt waren; mindestens 1 Injektion innerhalb der letzten 365 Tage. Bei Rezidiv des Makulaödems hatten die Patienten entweder 3 Injektionen Aflibercept (2,0 mg) oder Ranibizumab (0,5 mg) in monatlichen Abständen erhalten. Untersuchungszeitpunkte waren vor der Behandlung und 1 Monat nach der 3. Injektion. Erfasst wurden bestkorrigierter Fernvisus in logMAR, zentrale Netzhautdicke (CRT), subretinale Flüssigkeit (SRF), und Höhe der Pigmentepithelabhebung (PED-Höhe) im Bereich der Fovea sowie maximale Höhe der subretinalen Flüssigkeit (SRF max) und der Pigmentepithelabhebung (PED-Höhe max) im Bereich der Makula mittels Spectral-Domain-OCT. Veränderungen in Visus und OCT wurden zwischen beiden Gruppen verglichen, um mögliche Unterschiede in der Wirkung von Aflibercept und Ranibizumab zu ermitteln.

Ergebnisse: 60 Augen von 55 Patienten wurden untersucht. Die Aflibercept-Gruppe (n = 30) und die Ranibizumab-Gruppe (n = 30) zeigten keine statistisch signifikanten Unterschiede bezüglich Alter (p = 0,813), Anzahl vorheriger Ranibizumab-Injektionen (p = 0,127) oder Zeitraum seit der letzten Injektion (p = 0,523). Der Visus (logMAR) verbesserte sich in beiden Gruppen, jedoch nur in der Ranibizumab-Gruppe statistisch signifikant (von 0,50 ± 0,33 auf 0,44 ± 0,29 logMAR; p = 0,013). Die CRT nahm in der Aflibercept- (p = 0,133) und in der Ranibizumab-Gruppe (p = 0,043) ab. Die Höhe der PED verringerte sich in beiden Gruppen (Aflibercept p = 0,068; Ranibizumab p = 0,241). SRF, SRF max und PED-Höhe max zeigten einen statistisch signifikanten Rückgang in beiden Gruppen. Ein Vergleich des Therapieeffekts in der Aflibercept- und der Ranibizumab-Gruppe zeigte keine statistisch signifikanten Unterschiede bezüglich Visusänderung (logMAR; p = 0,680), CRT (p = 0,882), SRF (p = 0,871), PED-Höhe (p = 0,524), SRF max (p = 0,940) oder PED-Höhe max (p = 0,762) zwischen den beiden Medikamenten.

Schlussfolgerung: Aflibercept und Ranibizumab zeigen vergleichbare Resultate hinsichtlich Visus und OCT-morphologischen Parametern bei Patienten mit rezidivierender nAMD nach 4 Monaten. Es gab keine statistisch signifikanten Unterschiede im Therapieeffekt der beiden Medikamente in dieser Stichprobe.

Abstract

Background: To assess functional and morphological outcomes in patients with chronic recurrent neovascular age-related macular degeneration (nAMD) previously treated with ranibizumab, who were either switched from ranibizumab to aflibercept or received further ranibizumab injections.

Methods: Retrospective analysis of eyes with recurrent nAMD previously treated with ranibizumab. On recurrence of the macular oedema, patients had received either 3 injections of aflibercept (2.0 mg) or ranibizumab (0.5 mg) at 4 week intervals. Patients were examined before the first injection and four weeks after the last injection. The main outcome measures included change in visual acuity (VA) in logMAR, subfoveal central retinal thickness (CRT), subretinal fluid (SRF) and height of pigment epithelial detachment (PED height), as well as the maximum height of macular subretinal fluid (SRF max) and of macular pigment epithelial detachment (PED height max) in spectral-domain optical coherence tomography (OCT). Changes in VA and OCT were compared between the two groups to investigate differences in the therapeutic effects of aflibercept and ranibizumab.

Results: 60 eyes of 55 patients were included. The aflibercept group (n = 30) and the ranibizumab group (n = 30) showed no statistically significant differences in mean age (p = 0.813), number of prior injections of ranibizumab (p = 0.127) or time since last injection (p = 0.523). Mean VA logMAR improved in both groups, though only in the ranibizumab group was the difference significant (0.50 ± 0.33 to 0.44 ± 0.29 logMAR; p = 0.013; Table 1). CRT decreased in the aflibercept (p = 0.133) and ranibizumab groups (p = 0.043). PED height was reduced in both groups (aflibercept p = 0.068; ranibizumab p = 0.241). SRF, SRF max and PED height max showed statistically significant decreases in both groups. Comparison of the aflibercept and the ranibizumab groups showed no statistically significant differences between the two groups in change in VA logMAR (p = 0.680), CRT (p = 0.882), SRF (p = 0.871), PED height (p = 0.524), SRF max (p = 0.940) or PED height max (p = 0.762).

Conclusions: Aflibercept and ranibizumab were similarly effective in improving visual acuity and morphological parameters of patients with recurrent nAMD after four months. There were no statistically significant differences in the therapeutic effects of the two drugs.

Schlüsselwörter

Aflibercept - altersabhängige Makuladegeneration - Anti-VEGF - optische Kohärenztomografie - Ranibizumab

Key words

aflibercept - age-related macular degeneration - anti-VEGF - optical coherence tomography - ranibizumab

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