Two-year outcomes of intravitreal brolucizumab for neovascular age-related macular degeneration: treat, extend, and stop-protocol.

Age-related macular degeneration Brolucizumab Modified treat-and-extend regimen Vascular endothelial growth factor

Journal

Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie
ISSN: 1435-702X
Titre abrégé: Graefes Arch Clin Exp Ophthalmol
Pays: Germany
ID NLM: 8205248

Informations de publication

Date de publication:
12 Jul 2024
Historique:
received: 17 03 2024
accepted: 04 07 2024
revised: 10 06 2024
medline: 12 7 2024
pubmed: 12 7 2024
entrez: 12 7 2024
Statut: aheadofprint

Résumé

To investigate the real-world 2-year treatment outcomes of intravitreal brolucizumab (IVBr) for neovascular age-related macular degeneration (nAMD). This multicenter, prospective, and interventional study included 53 eyes treated with brolucizumab from October 2020 to August 2021 at 3 institutions. A modified treat-and-extend (TAE) regimen with predefined discontinuation criteria was used. The mTAE regimen was discontinued if patients responded positively and achieved a treatment interval of 16 weeks twice with no sign of recurrence. The number of patients discontinuing TAE and the visual and anatomic changes at 1 and 2 years after the first IVBr were evaluated. Thirty-eight eyes from 38 patients (71%) completed the 2-year observation period and 7 eyes from 7 patients experienced intraocular inflammation (IOI). Of these 38 patients, 18 (47%) could discontinue the TAE at a median [interquartile range] of 13.1 [12.9-16.8] months after the first IVBr. Best-corrected visual acuity, central subfield retinal thickness, and central choroidal thickness were significantly improved compared with baseline at both 1 and 2 years after the first IVBr (all P < 0.001). An extension study revealed a 1-year recurrence rate of 5.6% (standard deviation, 5.4%) after TAE discontinuation. While IOI is a concern with brolucizumab, careful observation allows discontinuing the TAE regimen in patients treated with IVBr. Moreover, brolucizumab may reduce the risk of recurrence after treatment interruption. UMIN Clinical Trials Registry ( http://www.umin.ac.jp/ ; R000050688 UMIN 000044374).

Identifiants

DOI: 10.1007/s00417-024-06577-9 PMID: 38995352
pubmed: 38995352
doi: 10.1007/s00417-024-06577-9
pii: 10.1007/s00417-024-06577-9
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Références

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Auteurs

Hana Yoshida (H)

Department of Ophthalmology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0431, Japan.
Department of Ophthalmology, Sano City Hospital, Sano-shi, Tochigi, Japan.

Satoru Inoda (S)

Department of Ophthalmology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0431, Japan. r1208is@jichi.ac.jp.
ORCID: 0000-0003-4577-8169

Hidenori Takahashi (H)

Department of Ophthalmology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0431, Japan.

Ryota Takahashi (R)

Department of Ophthalmology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0431, Japan.
Department of Ophthalmology, Haga Japanese Red Cross Hospital, Mooka-shi, Tochigi, Japan.

Yuto Hashimoto (Y)

Department of Ophthalmology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0431, Japan.

Hironori Takahashi (H)

Department of Ophthalmology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0431, Japan.

Hidetoshi Kawashima (H)

Department of Ophthalmology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0431, Japan.

Yasuo Yanagi (Y)

Department of Ophthalmology and Micro-Technology, Yokohama City University, Yokohama, Japan.
Retina Research Group, Duke-NUS Medical School, Singapore Eye Research Institute, Singapore Eye-ACP, National University of Singapore, 8 College Road, Singapore, 169857, Singapore.

Classifications MeSH