Evidence map›Paper›PMID 41166340›Full record

ArticlePloS one2025

A multicenter, single-arm study using a modified faricimab treat-and-extend regimen in patients with macular edema due to central retinal vein occlusion: RVOSTAR study design protocol.

Mineo Kondo, Masahiko Shimura, Akitaka Tsujikawa, Yuki Muraoka, Takahiro Kogo, Yuki Akiyama, Yuki Hama, Jun Tsujimura, Keisuke Iwasaki, Motohiro Kamei

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Faricimab: current evidence for the treatment of retinal vein occlusion.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Pooled it
  2. Article
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

10 authors.

Mineo KondoDepartment of Ophthalmology, Mie University Graduate School of Medicine, Mie, Japan.ORCID https://orcid.org/0000-0003-4569-1792
Masahiko ShimuraDepartment of Ophthalmology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan.
Akitaka TsujikawaDepartment of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID https://orcid.org/0000-0003-0779-7799
Yuki MuraokaDepartment of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Takahiro KogoDepartment of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Yuki AkiyamaDepartment of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Yuki HamaDepartment of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Jun TsujimuraChugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Keisuke IwasakiChugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Motohiro KameiDepartment of Ophthalmology, Aichi Medical University, Aichi, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAnti-vascular endothelial growth factor (anti-VEGF) agents are generally considered to be the first line of therapy for macular edema due to retinal vein occlusion (RVO-ME). However, current anti-VEGF treatment regimens in Japan are unable to maintain long-term vision improvement, particularly in patients with central RVO-ME (CRVO-ME). Faricimab is a dual angiopoietin-2/VEGF inhibitor approved for the treatment of RVO-ME in Japan. The RVOSTAR study is being conducted to evaluate the long-term maintenance of vision outcomes with faricimab using a modified treat-and-extend (T&E) regimen in treatment-naïve Japanese patients with CRVO-ME or hemi-RVO-ME (HRVO-ME) and to assess the factors affecting visual acuity and treatment intervals. METHODS AND

designRVOSTAR (Japan Registry of Clinical Trials; jRCTs041250001) is an unmasked, single-arm, multicenter, prospective interventional study. Patients with CRVO-ME or HRVO-ME will 1) receive faricimab 6 mg every 4 weeks (≤6 injections) until ME is resolved; 2) be observed with no treatment until ME reoccurs, based on pre-specified central subfield thickness (CST) criteria; and then 3) be treated according to a T&E regimen up to 72 weeks, with dosing intervals based on time to relapse and adjusted by 4-week increments (minimum interval: every 4 weeks; maximum interval: no limit). Vision outcomes include best-corrected visual acuity (BCVA) and CST. The primary endpoint is the change from baseline in BCVA at week 72. Safety outcomes include ocular and non-ocular adverse events.

conclusionRVOSTAR will evaluate the long-term maintenance of vision outcomes with a modified faricimab T&E regimen in patients with CRVO-ME or HRVO-ME while reducing the burden associated with frequent injections. The findings from this study may help to optimize dosing frequency in clinical practice.

Indexed as

Angiogenesis InhibitorsMacular EdemaRetinal Vein OcclusionAgedAntibodies, BispecificFemaleHumansJapanMaleMiddle AgedMulticenter Studies as TopicProspective StudiesTreatment OutcomeVascular Endothelial Growth Factor AVisual AcuityAngiogenesis InhibitorsAntibodies, BispecificfaricimabVascular Endothelial Growth Factor A

Identifiers

PMID41166340
PMCPMC12574838

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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 OpenQuestion graph.