Evidence map›Paper›PMID 39388397›Full record

ArticlePloS one2024

Optimization of individualized faricimab dosing for patients with diabetic macular edema: Protocol for the SWAN open-label, single-arm clinical trial.

Takao Hirano, Toshinori Murata, Shintaro Nakao, Masahiko Shimura, Miho Nozaki, Kiyoshi Suzuma, Taiji Nagaoka, Masahiko Sugimoto, Yoshihiro Takamura, Tomoaki Murakami and 3 more

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Takao HiranoDepartment of Ophthalmology, Shinshu University School of Medicine, Nagano, Japan.ORCID https://orcid.org/0000-0003-3601-8053
Toshinori MurataDepartment of Ophthalmology, Shinshu University School of Medicine, Nagano, Japan.
Shintaro NakaoDepartment of Ophthalmology, Juntendo University School of Medicine, Tokyo, Japan.
Masahiko ShimuraDepartment of Ophthalmology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan.
Miho NozakiDepartment of Ophthalmology, Laser Eye Center, Nagoya City University East Medical Center, Aichi, Japan.
Kiyoshi SuzumaDepartment of Ophthalmology, Kagawa University Faculty of Medicine, Kagawa, Japan.
Taiji NagaokaDepartment of Ophthalmology, Asahikawa Medical University, Hokkaido, Japan.
Masahiko SugimotoDepartment of Ophthalmology, Yamagata University Faculty of Medicine, Yamagata, Japan.
Yoshihiro TakamuraDepartment of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Tomoaki MurakamiDepartment of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Keisuke IwasakiChugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Jun TsujimuraChugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Shigeo YoshidaDepartment of Ophthalmology, Kurume University School of Medicine, Fukuoka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn patients with diabetic macular edema (DME) from YOSEMITE/RHINE, dual angiopoietin-2/vascular endothelial growth factor-A (VEGF-A) inhibition with faricimab resulted in visual/anatomic improvements with extended dosing. The SWAN trial (jRCTs031230213) will assess the efficacy, durability, and safety of faricimab during the treatment maintenance phase in patients with DME using a treat-and-extend (T&E)-based regimen adapted to clinical practice and the characteristics of patients achieving extended dosing intervals.

methodsSWAN is a 2-year, open-label, single-arm, interventional, multicenter trial enrolling adults with center-involving DME. All patients will receive three initial faricimab 6.0 mg doses every 4 weeks (Q4W). From week 12 onwards, in patients without active DME, dosing intervals will be extended in 8-week increments up to Q24W. In contrast, patients with active DME (central subfield thickness [CST] >325 μm and intraretinal fluid [IRF] or subretinal fluid [SRF] resulting in vision loss/disease aggravation) will receive a dose within a day and the dosing interval will be shortened by 4 weeks to a minimum of Q8W relative to the previous dosing interval. Recruitment commenced in August 2023 across a planned 16 sites in Japan.

resultsThe primary endpoint is change in best-corrected visual acuity (BCVA) from baseline at 1 year (averaged over weeks 52, 56, and 60). Key secondary endpoints include: change from baseline in BCVA, CST, and National Eye Institute Visual Function Questionnaire scores over time; proportion of patients with BCVA (decimal visual acuity) ≥0.5, ≥0.7, ≥1.0, or ≤0.1; proportion of patients with absence of DME, and IRF and/or SRF over time. Safety endpoints include incidence/severity of ocular/nonocular adverse events.

conclusionsThe SWAN trial is expected to provide evidence to support individualized faricimab dosing regimens, with the potential to reduce the burden of frequent treatments on patients, caregivers, and healthcare systems.

Indexed as

Diabetic RetinopathyMacular EdemaAdultAgedAngiogenesis InhibitorsAngiopoietin-2Antibodies, Monoclonal, HumanizedFemaleHumansMaleMiddle AgedMulticenter Studies as TopicTreatment OutcomeVascular Endothelial Growth Factor AVisual AcuityAngiogenesis InhibitorsAngiopoietin-2ANGPT2 protein, humanAntibodies, Monoclonal, HumanizedVascular Endothelial Growth Factor A

Identifiers

PMID39388397
PMCPMC11466402

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.