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.

IF 2.8 3区 医学 Q1 OPHTHALMOLOGY
Eye Pub Date : 2024-12-24 DOI:10.1038/s41433-024-03550-y
Clare Bailey, Manju Chandran, Richard Gale, Nirodhini Narendran, James Talks, Hellen McGoey, Zinab Keshk, Peter Morgan-Warren, Helmut Allmeier, Tobias Machewitz, Praveen J Patel, Deepali Varma
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引用次数: 0

Abstract

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.

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来源期刊
Eye
Eye 医学-眼科学
CiteScore
6.40
自引率
5.10%
发文量
481
审稿时长
3-6 weeks
期刊介绍: Eye seeks to provide the international practising ophthalmologist with high quality articles, of academic rigour, on the latest global clinical and laboratory based research. Its core aim is to advance the science and practice of ophthalmology with the latest clinical- and scientific-based research. Whilst principally aimed at the practising clinician, the journal contains material of interest to a wider readership including optometrists, orthoptists, other health care professionals and research workers in all aspects of the field of visual science worldwide. Eye is the official journal of The Royal College of Ophthalmologists. Eye encourages the submission of original articles covering all aspects of ophthalmology including: external eye disease; oculo-plastic surgery; orbital and lacrimal disease; ocular surface and corneal disorders; paediatric ophthalmology and strabismus; glaucoma; medical and surgical retina; neuro-ophthalmology; cataract and refractive surgery; ocular oncology; ophthalmic pathology; ophthalmic genetics.
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