Exit Strategy for Treatment of Neovascular Age-Related Macular Degeneration in a Real-World Setting: Wishful Thinking?

Abstract

Introduction To analyze our outcome for patients with neovascular age-related macular degeneration (nAMD) treated with aflibercept in a treat-and-extend regimen pursuing an exit strategy (with best possible adherence to the “Bern” exit criteria) over 6 years in a real-world setting. The primary objective of the study was to investigate the proportion of patients who were able to achieve and maintain treatment exit.

Methods This is a retrospective chart review study of treatment-naïve patients diagnosed with nAMD receiving intravitreal aflibercept injections performed at our department with at least 2 years of follow-up visits. The primary outcome was the percentage of patients able to achieve and maintain the treatment exit regarding intravitreal anti-VEGF injections. Further outcome measures were best-corrected visual acuity (BCVA), incidence of recurrence after treatment cessation, duration of therapy, and number and intervals of injections.

Results There were 31 eyes of 25 patients included in this retrospective study. The observation period was from September 1, 2017 to August 31, 2023. Of all included patient eyes, 22.6% (n = 7) reached exit criteria. Of all the “exit” patients, 28.6% (n = 2) suffered from disease relapse and therapy was restarted at a mean (± SD) of 41.5 ± 12.5 weeks (range: 29 to 54 weeks). Regarding the eyes that met treatment exit, 5 of 31 (16.1%) had no disease recurrence in the observed study period. The median BCVA (Snellen decimal; ± interquartile range: IQR) changed from 0.63 (0.27) at baseline to 0.63 (0.4) in the first year, 0.63 (0.3) in the second year, 0.63 (0.46) in the third year, 0.63 (0.3) in the fourth year, 0.63 (0.4) in the fifth year, and 0.4 (0.04) in the sixth year. The median number of injections (± IQR) per eye in the first year of treatment was 8 (2), in the second year 5 (2), in the third year 5 (2.5), in the fourth year 5 (1), in the fifth year 3 (0.8), and in the sixth year 3 (0). Extension of the treatment interval after the loading phase in weeks was achieved up to a median (± IQR) of 5.8 (4) in the first year, 8.4 (6) in the second year, 8 (5.7) in the third year, 9.4 (5.6) in the fourth year, 7 (6.9) in the fifth year, and 8.4 (3.1) in the sixth year of observation.

Discussion Our study indicates a lower rate of patients reaching exit criteria with a treat-and-extend regimen compared to clinical study settings, and a similar recurrence rate of nAMD after treatment cessation. Nonadherence to a strict treat-and-extend protocol might influence the result.

Zusammenfassung

Einleitung Ziel dieser Studie ist es, unsere Ergebnisse in Bezug auf Patienten mit neovaskulärer altersbedingter Makuladegeneration (nAMD) zu analysieren, die mit Aflibercept in einem “Treat-and-Extend”-Schema behandelt wurden, um eine Exit-Strategie zu verfolgen (mit bestmöglicher Adhärenz an die “Bern”-Exit-Kriterien), dies über einen Zeitraum von sechs Jahren in einem realen Versorgungsumfeld. Das Hauptziel der Studie war es, den Anteil der Patienten zu untersuchen, die ein Behandlungsende erreichen und aufrechterhalten konnten.

Methodik Dies ist eine retrospektive Aktenanalyse von therapienaiven Patienten, bei welchen eine nAMD diagnostiziert und intravitreale Aflibercept-Injektionen in unserer Klinik verabreicht wurden, mit mindestens zwei Jahren Nachbeobachtung. Der primäre Endpunkt war der Prozentsatz an Patienten, die in der Lage waren, das Behandlungsende im Hinblick auf intravitreale Anti-VEGF-Injektionen zu erreichen und aufrechtzuerhalten. Weitere Studien-Endpunkte waren best-korrigierte Sehschärfe (BCVA), Auftreten eines Rezidivs nach Behandlungsabbruch, Therapiedauer sowie Anzahl und Intervalle der Injektionen.

Resultate 31 Augen von 25 Patienten wurden in diese retrospektive Studie eingeschlossen. Der Beobachtungszeitraum erstreckte sich vom 1. September 2017 bis zum 31. August 2023. 22.6% der eingeschlossenen Augen (n = 7) erreichten die Exit-Kriterien. 28.6% (n = 2) aller “Exit”-Patienten erlitten ein Rezidiv und die Therapie wurde nach einem Mittelwert (± SD) von 41.5 ± 12.5 Wochen (Spanne: 29 bis 54 Wochen) wieder aufgenommen. Bezogen auf die Augen, die das Behandlungsende erreichten, hatten 5 von 31 (16.1%) während des beobachteten Studienzeitraums keinen Krankheitsrückfall. Die mediane BCVA (Snellen dezimal; ± Interquartilsabstand: IQR) veränderte sich von 0.63 (0.27) zu Beginn auf 0.63 (0.4) im 1. Jahr, 0.63 (0.3) im 2. Jahr, 0.63 (0.46) im 3. Jahr, 0.63 (0.3) im vierten Jahr, 0.63 (0.4) im fünften Jahr und 0.4 (0.04) im sechsten Jahr. Die mediane Anzahl der Injektionen (± IQR) pro Auge im 1. Behandlungsjahr betrug 8 (2), beim 2. Jahr 5 (2), im 3. Jahr 5 (2.5), im 4. Jahr 5 (1), im 5. Jahr 3 (0.8) und im 6. Jahr 3 (0). Die Verlängerung des Behandlungsintervalls nach der Ladephase in Wochen wurde bis zu einem Median (± IQR) von 5.8 (4) im 1. Jahr, 8.4 (6) im 2. Jahr, 8 (5,7) im 3. Jahr, 9.43 (5.6) im 4. Jahr, 7 (6.9) im 5. Jahr und 8.4 (3.1) im 6. Beobachtungsjahr erreicht.

Schlussfolgerung Unsere Studie weist verglichen mit anderen klinischen Studien auf eine geringere Rate an Patienten, die mit einem “Treat-and-Extend”-Schema die Exit-Kriterien erreichen, hin. Die Rezidivrate der nAMD nach Behandlungsende war jedoch ähnlich. Eine mangelnde Adhärenz zum strikten “Treat-and-Extend”-Protokoll könnte das Ergebnis beeinflusst haben.

Keywords

neovascular age-related macular degeneration - anti-VEGF - treat-and-extend - exit-strategy - aflibercept

Schlüsselwörter

neovaskuläre altersbedingte Makuladegeneration - Anti-VEGF - Treat-and-Extend - Exit-Strategie - Aflibercept

Publication History

Received: 10 October 2024

Accepted: 07 January 2025

Article published online:
05 February 2025

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