2-year results from an observational study of proactive treatment regimens with intravitreal aflibercept 2 mg in patients with nAMD in clinical practice: XTEND study UK cohort.

Autor: Bailey C; Department of Ophthalmology, University Hospitals Bristol & Weston NHS Foundation Trust, Bristol, UK. Clare.Bailey@uhbw.nhs.uk., Chandran M; Department of Ophthalmology, Frimley Health NHS Foundation Trust, Frimley, UK., Gale R; Department of Ophthalmology, Hull York Medical School, University of York, York Teaching Hospitals NHS Foundation Trust, York, UK., Narendran N; Department of Ophthalmology, The Royal Wolverhampton Hospitals NHS Trust NHS Foundation Trust, Wolverhampton, UK.; School of Life and Health Sciences, Aston University, Birmingham, UK.; UCL Institute of Ophthalmology, Faculty of Brain Sciences, London, UK., Talks J; Department of Ophthalmology, Newcastle Hospitals NHS Foundation Trust, Newcastle, UK., McGoey H; Department of Medical Affairs, Bayer Plc, Reading, Berkshire, UK., Keshk Z; Department of Medical Affairs, Bayer Plc, Reading, Berkshire, UK., Morgan-Warren P; Bayer Consumer Care AG, Basel, Switzerland., Allmeier H; Bayer Consumer Care AG, Basel, Switzerland., Machewitz T; Bayer AG, Berlin, Germany., Patel PJ; UCL Institute of Ophthalmology, Faculty of Brain Sciences, London, UK.; National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital, NHS Foundation Trust, London, UK., Varma D; Department of Ophthalmology, Sunderland Eye Infirmary, South Tyneside & Sunderland NHS Foundation Trust, Sunderland, UK.
Jazyk: angličtina
Zdroj: Eye (London, England) [Eye (Lond)] 2024 Dec 24. Date of Electronic Publication: 2024 Dec 24.
DOI: 10.1038/s41433-024-03550-y
Abstrakt: Objectives: The 36-month XTEND (NCT03939767) multicentre, observational, prospective study examined the effectiveness of proactive treatment regimens of intravitreal aflibercept (IVT-AFL) 2 mg in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) in routine clinical practice. The 12- and 24-month outcomes from the XTEND UK cohort are reported.
Methods: Patients aged ≥50 years with nAMD planned to receive IVT-AFL 2 mg were eligible. After three initial monthly IVT-AFL injections, treatment intervals could be extended in 2- to 4-weekly increments to a maximum of 16 weeks (8-week minimum treatment interval). Endpoints included mean change from baseline in best-corrected visual acuity (BCVA) and central subfield thickness (CST) at month (M) 12 and M24. Treatment intervals and safety were assessed. Statistics were descriptive.
Results: In the UK, 496 patients from 23 centres were treated (mean age 79.7 years, 64.3% female). From a baseline BCVA (mean ± SD) of 55.2 ± 15.8 letters, mean (95% confidence interval [CI]) change in BCVA was +3.4 (2.0, 4.9) letters at M12 and +1.3 (- 0.3, 2.9) letters at M24. From a baseline CST (mean ± SD) of 395 ± 143 μm, mean (95% CI) change in CST was -105 ( 121, -89) μm at M12 and -105 (- 122, -88) μm at M24. By M12 and M24, patients had received a mean ± SD of 7.4 ± 2.4 and 10.7 ± 4.6 injections, respectively. Outcomes in patients enrolled prior to and during the COVID-19 pandemic were comparable. No new safety concerns were identified.
Conclusions: Despite the COVID-19 pandemic, patients in the UK achieved and maintained clinically meaningful improvements in functional and anatomic outcomes through M24.
Trial Registration: ClinicalTrials.gov identifier, NCT03939767.
Competing Interests: Competing interests: CB: Travel support/lecture fees from Alimera Sciences, Apellis, Bayer, Novartis, and Roche; and attendance at advisory board meetings for Apellis, Bayer, Boehringer Ingelheim, Janssen, Novartis, and Roche. MC: Nothing to disclose. RG: Consultant/advisory boards: Allergan, Alimera, Bayer, Novartis, and Santen; Educational travel grants: Allergan, Bayer, Heidelberg, and Novartis; Research grants: Allergan, Bayer, Novartis, and Roche. NN: Nothing to disclose. JT: Advisory board member, speaker fees, and research support: Bayer and Novartis; Research grants: Boehringer Ingelheim and Roche; Consultant: Bayer. HM: Employee of Bayer Plc, UK. ZK: Employee of Bayer Plc, UK. PMW: Employee of Bayer Consumer Care AG, Basel, Switzerland. HA: Employee of Bayer Consumer Care AG, Basel, Switzerland. TM: Employee of Bayer AG, Berlin, Germany. PJP: Honoraria/attendance at advisory boards for Bayer, Boehringer Ingelheim and Roche, Speaker fees from Bayer and Roche. Educational travel grants from Roche and Bayer. DV: Speaker fees, AbbVie, Bayer, Novartis and Roche; Honoraria/attendance at advisory boards for Bayer, AbbVie, Novartis, Roche and Teva Pharmaceuticals; Educational travel grants from AbbVie, Roche and Bayer; Principal investigator in clinical trials for AbbVie, Bayer, Novartis and Roche.
(© 2024. The Author(s).)
Databáze: MEDLINE
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