Wirksamkeit von Aflibercept bei Patienten mit mehr als 10 vorangegangenen intravitrealen Ranibizumab-Injektionen

Zusammenfassung

Hintergrund: Die intravitreale Injektion des anti-VEGF-Inhibitors Ranibizumab gilt seit 2007 als Standardtherapie für die Behandlung der exsudativen AMD. Trotz konsequenter Behandlung mit Ranibizumab kann nicht bei allen Patienten eine vollständige Befundberuhigung erreicht werden. Seit 2012 steht mit dem rekombinanten Fusionsprotein Aflibercept eine 2. gleichwertige Therapieoption zur Verfügung. Wir untersuchten, ob Patienten, die scheinbar nicht mehr auf Ranibizumab ansprechen, von einem Wechsel auf Aflibercept profitieren. Methoden: In diese retrospektive Studie wurden 83 Augen von 81 Patienten eingeschlossen, bei denen seit Zulassung von Aflibercept 2012 die Indikation zum Therapiewechsel nach therapierefraktärer Ranibizumab-Behandlung gestellt wurde. Einschlusskriterien waren ein Alter ≥ 50 Jahre und mindestens 10 stattgehabte Ranibizumab-IVI (IVI: intravitreale Injektion) am Studienauge vor Therapiewechsel auf Aflibercept. Ausgeschlossen wurden Patienten, die zusätzlich andere schwerwiegende visuslimitierende Erkrankungen aufwiesen. Primäre Endpunkte waren die Visusentwicklung und die Beurteilung der zentralen Netzhautdicke (CMT) im OCT. Sekundäre Endpunkte waren der prozentuale Anteil Augen, die nach Aflibercept-IVI keine Aktivität der choroidalen Neovaskularisation (CNV) mehr zeigten und der Anteil der Augen mit Zeilengewinn/-verlust. Die statistische Analyse erfolgte mittels SPSS, wobei ein p < 0,05 als statistisch signifikant galt. Ergebnisse: Der Visus vor Aflibercept betrug im Mittel 0,83 ± 0,34 logMAR mit einer leichten, jedoch nicht signifikanten Verbesserung auf 0,79 ± 0,33 logMAR nach der 3. Aflibercept-IVI (p = 0,205). Hingegen zeigte sich eine signifikante Reduktion der zentralen Netzhautdicke von 451,4 ± 263,0 µm auf 288,2 ± 128,2 µm (p = 0,0001). Es zeigte sich insgesamt bei 73 % der Augen ein besserer oder gleicher Visus, bei 27 % der Augen sahen wir trotz Therapieumstellung eine progrediente Visusverschlechterung. Dabei profitieren v. a. Patienten mit schlechtem Ausgangsvisus signifikant von der Umstellung auf Aflibercept (p = 0,001). Schlussfolgerungen: Bei Patienten, die offensichtlich nicht mehr auf die Therapie mit Ranibizumab ansprechen, kann ein Wechsel auf das Präparat Aflibercept zu einer Inaktivierung der CNV und zu einer Visusstabilisierung führen.

Abstract

Background: Since 2007, the standard treatment for age related macular degeneration has been intravitreal injection of ranibizumab. However, despite continuous treatment, some patients fail to achieve remission or stabilisation of the disease. Since 2012, the recombinant fusion protein aflibercept has been available as an alternative treatment. In this study, we investigated whether patients who appear to be resistant to ranibizumab would benefit from treatment with aflibercept. Methodology: This retrospective study covered 83 eyes of 81 patients, for whom treatment switch from ranibizumab to aflibercept was indicated. Inclusion criteria were an age ≥ 50 years and at least 10 ranibizumab injections before a switch to aflibercept. Patients with severely impaired visual acuity were excluded. Primary outcomes were improvement or loss of visual acuity (VA) and evaluation of central macular thickness (CMT) via SD-OCT. Secondary endpoints were percentage of eyes without activity of the choroidal neovascular membrane after aflibercept injections and loss or gain of letters on the visual chart. Statistical analysis was performed using SPSS. Results: VA was 0.83 ± 0.34 logMAR before the first aflibercept injection, with a slight but not statistically significant improvement up to 0.79 ± 0.33 logMAR after the third aflibercept injection (p = 0.205). On the other hand, there was a clear reduction of CMT in OCT, from 451.4 ± 263.0 to 288.2 ± 128.2 µm (p = 0.0001). Overall, 73 % of eyes exhibited better or stable VA and 27 % of eyes lost VA. Interestingly, eyes with worse initial VA gained greater benefit from the switch to aflibercept (p = 0.001). Conclusion: A switch to aflibercept may lead to stabilisation of choroidal neovascularisation and thus stabilise the visual acuity for patients who appear to be no longer responsive to treatment with ranibizumab.

Schlüsselwörter

Retina - Chorioidea - Pathologie

Key words

retina - choroid - pathology

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