Treatment of age-related macular degeneration with aflibercept using a treat, extend and fixed protocol; A 4-year study of treatment outcomes, durability, safety and quality of life (An extension to the MATE randomised controlled trial)

© 2023 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd..

PURPOSE: Data are limited pertaining to the long-term benefits of aflibercept treatment for neovascular age-related macular degeneration (nAMD). The aim of this study was to provide outcomes, safety, durability and quality-of-life data with aflibercept using a modified treat, extend and fixed regime over 4 years.

METHODS: Prospective, multicentre, single cohort observational study of treatment-naïve nAMD participants treated with aflibercept as 2-year extension of the MATE-trial that compared early and late Treat-and-Extend for 2 years. Refracted ETDRS best corrected visual acuity (BCVA), central retinal thickness (CRT), treatment interval and adverse events were assessed. Quality-of-life was measured using the Macular Disease Dependent Quality of Life (MacDQoL) and Macular Disease Treatment Satisfaction Questionnaires (MacTSQ).

RESULTS: Twenty-six of 40 participants completing the MATE-trial were enrolled with 20 completing the total 4-year study. Mean BCVA was 60.7 at Month 0 and 64.8 ETDRS letters at Month 48 while CRT decreased from 423.7 μm to 292.2 μm. Five participants discontinued treatment due to inactivity. The mean number of treatments and visits for the remaining participants was 27 and 30.0, respectively, with treatment intervals extended to 12 weeks in four participants at Month 48. Both AMD-specific QoL and treatment satisfaction remained stable between Months 0 and 48 and mean BCVA significantly correlated with AMD-specific QoL scores at Months 12, 24 and 48.

CONCLUSIONS: Results suggest that BCVA can be maintained over 48 months when following a treat-extend-and-fix regimen of aflibercept with intervals out to 12 weeks, while maintaining AMD-specific QoL and treatment satisfaction.

Medienart:

E-Artikel

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

Zur Gesamtaufnahme - volume:102

Enthalten in:

Acta ophthalmologica - 102(2024), 3 vom: 13. Apr., Seite e328-e338

Sprache:

Englisch

Beteiligte Personen:

Airody, Archana [VerfasserIn]
Baseler, Heidi A [VerfasserIn]
Seymour, Julie [VerfasserIn]
Allgar, Victoria [VerfasserIn]
Mukherjee, Rajarshi [VerfasserIn]
Downey, Louise [VerfasserIn]
Dhar-Munshi, Sushma [VerfasserIn]
Mahmood, Sajjad [VerfasserIn]
Balaskas, Konstantinos [VerfasserIn]
Empeslidis, Theo [VerfasserIn]
Hanson, Rachel L W [VerfasserIn]
Dorey, Tracey [VerfasserIn]
Szczerbicki, Tom [VerfasserIn]
Sivaprasad, Sobha [VerfasserIn]
Gale, Richard P [VerfasserIn]

Links:

Volltext

Themen:

15C2VL427D
Aflibercept
Angiogenesis Inhibitors
Clinical Trial Protocol
Durability
EC 2.7.10.1
Journal Article
Neovascular age‐related macular degeneration
Quality of life
Ranibizumab
Receptors, Vascular Endothelial Growth Factor
Recombinant Fusion Proteins
Safety
ZL1R02VT79

Anmerkungen:

Date Completed 10.04.2024

Date Revised 10.04.2024

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1111/aos.15774

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM362720053