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Pro-re-nata-anti-VEGF-Behandlungsergebnisse bei neovaskulärer altersabhängiger Makuladegeneration in der klinischen Routineversorgung: Vergleich von Einzel- mit 3er-Injektionen

Pro re nata anti-VEGF treatment results for neovascular age-related macular degeneration in routine clinical treatment: comparison of single with triple injections

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Zusammenfassung

Hintergrund

Zur Behandlung der neovaskulären altersabhängigen Makuladegeneration (nAMD) stehen Behandlungsstrategien mit kontinuierlichem und bedarfsorientiertem („pro re nata“ [PRN]) Injektionsschema zur Verfügung. Bislang wurde das PRN-Behandlungsschema mit Einzelinjektionen bei Reaktivierung nicht mit dem PRN-Behandlungsschema mit Dreierinjektionen bei Reaktivierung (IVAN-Schema) verglichen.

Ziele der Arbeit

Vergleich der beiden nAMD-PRN-Behandlungsschemata mit Einzel- und Dreierinjektionen hinsichtlich Behandlungsergebnissen und -intensität unter klinischen Routinebedingungen in einer retrospektiven Fallserie in 2 deutschen Behandlungszentren.

Material und Methoden

Behandlungsnaive nAMD-Patienten, bei denen eine Therapie mit Einzel- oder Dreierinjektionsschema initiiert wurde, wurden eingeschlossen. Endpunkte waren bestkorrigierter Visus (LogMAR), zentrale Netzhautdicke in der optischen Kohärenztomographie (μm) und Anzahl der Injektionen. Dies wurde jeweils für die Zeitpunkte 3, 6, 12, 18 und 24 Monate nach Therapiebeginn analysiert.

Ergebnisse

146 Patienten mit Einzel- und 148 Patienten mit Dreierinjektionsschema wurden eingeschlossen. Nach 24 Monaten gab es weder beim bestkorrigierten Visus (Einzel- vs. Dreierinjektionsschema: 0,50 ± 0,42 vs. 0,56 ± 0,42, p = 0,14) noch bei der zentralen Netzhautdicke (303 ± 76,2 vs. 306 ± 110, p = 0,79) einen signifikanten Unterschied zwischen den beiden Behandlungsschemata. Auch die Anzahl der Injektionen unterschied sich nicht signifikant zwischen beiden Gruppen (13 ± 4,4 vs. 12 ± 5,4, p = 0,31). Dies war für alle betrachteten Zeitpunkte der Fall.

Diskussion

Die PRN-Behandlungsschemata mit Einzel- und Dreierinjektionen unterscheiden sich nach 24 Monaten nicht hinsichtlich funktioneller und struktureller Behandlungsergebnisse und sind entsprechend als äquivalent zu bewerten. Zur Beurteilung des langfristigen Therapieerfolges über 24 Monate hinaus sind weitere Studien notwendig.

Abstract

Background

Different injection regimens from continuous to pro re nata (PRN) have been proposed for treatment of neovascular age-related macular degeneration (nAMD). So far the PRN single injection on reactivation regimen has not been compared to the PRN triple injection on reactivation regimen (IVAN scheme).

Objective

Comparison of the two nAMD PRN injection regimens with single and triple injections on reactivation in a real-world setting in a retrospective case series in two German treatment centers.

Material and methods

Naïve nAMD patients, who started treatment according to either the single or triple injection regimen were included. Endpoints were best corrected visual acuity (LogMAR), central retinal thickness on optical coherence tomography (μm) and number of injections, all at 3, 6, 12, 18 and 24 months after treatment initiation.

Results

A total of 146 patients with single injection and 148 patients with triple injection regimens were included. There were no significant differences between the two treatment regimens in best corrected visual acuity (single vs. triple injection scheme: 0.50 ± 0.42 vs. 0.56 ± 0.42, p = 0.14), central retinal thickness (303 ± 76.2 vs. 306 ± 110, p = 0.79) and number of injections (13 ± 4.4 vs. 12 ± 5.4, p = 0.31). This was the case for all analyzed time points.

Conclusion

There were no significant functional or morphological differences between the two PRN injection regimens with single and triple injections on reactivation after 24 months. For evaluation of long-term therapy results further studies are warranted.

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Abbreviations

ANCHOR:

Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration

AURA:

A retrospective non-interventional study to assess the effectiveness of existing Anti-vascUlar endothelial growth factor [anti-VEGF] treatment Regimens in patients with wet Age-related macular degeneration

CATT:

Comparison of Age-related macular degeneration treatment trials

HARBOR:

pHase III, double-masked, multicenter, randomized, Active treatment-controlled study of the efficacy and safety of 0,5 and 2,0mg Ranibizumab administered monthly or on an as-needed Basis (PRN) in patients with subfoveal neOvasculaR age-related macular degeneration

IVAN:

A randomised controlled trial of alternative treatments to Inhibit VEGF in Age-related choroidal Neovascularisation

MARINA:

Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration

PrONTO:

Prospective Optical Coherence Tomography Imaging of Patients with Neovascular Age-Related Macular Degeneration Treated with intraOcular Ranibizumab

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Danksagung

Wir danken unserer studentischen Hilfskraft Frau Margarita Delles, die uns bei der Digitalisierung der Patientendaten unterstützte. Darüber hinaus geht unser Dank an Frau Charlotte Ohlmeier für die gute Zusammenarbeit zur Projektvorbereitung.

Förderung

Dieses Projekt wurde durch die Jackstädt Stiftung und die German Scholars Organisation/Else Kröner-Fresenius-Stiftung (GSO/EKFS 16) gefördert.

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Authors and Affiliations

  1. Universitäts-Augenklinik Bonn, Ernst-Abbe-Str. 2, 53127, Bonn, Deutschland

    M. W. M. Wintergerst, P. P. Larsen, F. G. Holz & R. P. Finger

  2. St. Franziskus-Hospital Münster, Hohenzollernring 74, 48145, Münster, Deutschland

    B. Heimes & D. Pauleikhoff

Authors
  1. M. W. M. Wintergerst
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Correspondence to M. W. M. Wintergerst.

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Interessenkonflikt

M.W.M. Wintergerst, P.P. Larsen und B. Heimes geben an, dass kein Interessenkonflikt besteht. D. Pauleikhoff gibt folgenden Interessenkonflikt an: Beratung bei Bayer, Novartis, Alcon, Roche, Heidelberg Engineering, Carl Zeiss MediTec Inc. F.G. Holz gibt folgenden Interessenkonflikt an: Berater bei Heidelberg Engineering, Novartis, Bayer, Roche/Genentech, Acucela, Boehringer Ingelheim, Alcon, Allergan, Optos, Carl Zeiss MediTec Inc, Merck, Kanghong, Thea. R.P. Finger gibt folgenden Interessenkonflikt an: Beratung und Vortragshonorare von Bayer, Novartis, Santen, Opthea, Novelion, RetinaImplant, Oxford Innovation

Für diesen Beitrag wurden vom Autor keine Studien an Menschen oder Tieren durchgeführt. Er beschreibt eine retrospektive Studie ohne Einfluss auf die Behandlung.

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Wintergerst, M.W.M., Larsen, P.P., Heimes, B. et al. Pro-re-nata-anti-VEGF-Behandlungsergebnisse bei neovaskulärer altersabhängiger Makuladegeneration in der klinischen Routineversorgung: Vergleich von Einzel- mit 3er-Injektionen. Ophthalmologe 116, 441–446 (2019). https://doi.org/10.1007/s00347-018-0747-4

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