Evidence map›Paper›PMID 33436683›Full record

Trial reportScientific reports2021

The randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients.

Toshinori Murata, Mineo Kondo, Makoto Inoue, Shintaro Nakao, Rie Osaka, Chieko Shiragami, Kenji Sogawa, Akikazu Mochizuki, Rumiko Shiraga, Yohei Ohashi and 4 more

Erratum issuedOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.8field-weighted citation impact, top 10% of its field
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

11 citing papers in PubMed, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 2 countries.

Toshinori MurataDepartment of Ophthalmology, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, Japan. murata@shinshu-u.ac.jp.
Mineo KondoDepartment of Ophthalmology, Mie University Graduate School of Medicine, Mie, Japan.
Makoto InoueDepartment of Ophthalmology, Kyorin Eye Center, Kyorin University School of Medicine, Tokyo, Japan.
Shintaro NakaoDepartment of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Rie OsakaDepartment of Ophthalmology, Kagawa University Faculty of Medicine, Kagawa, Japan.
Chieko ShiragamiDepartment of Ophthalmology, Kagawa University Faculty of Medicine, Kagawa, Japan.
Kenji SogawaDepartment of Ophthalmology, Asahikawa Medical University, Hokkaido, Japan.
Akikazu MochizukiNovartis Pharma K.K., Tokyo, Japan.
Rumiko ShiragaNovartis Pharma K.K., Tokyo, Japan.
Yohei OhashiNovartis Pharma K.K., Tokyo, Japan.
Takeumi KanekoNovartis Pharma K.K., Tokyo, Japan.
Chikatapu ChandrasekharNovartis Healthcare Pvt. Ltd., Hyderabad, India.
Akitaka TsujikawaDepartment of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Motohiro KameiDepartment of Ophthalmology, Aichi Medical University, Aichi, Japan.
Novartis (Japan) · JPKagawa University · JPAichi Medical University · JPAsahikawa Medical University · JPKyorin University · JPKyoto University · JPKyushu University · JPMie University · JPNovartis (India) · INShinshu University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The ZIPANGU study assessed the efficacy and safety of ranibizumab as a one loading dose + pro re nata (one + PRN) regimen with/without focal/grid laser among treatment-naïve patients suffering from macular edema (ME) following branch retinal vein occlusion (BRVO). ZIPANGU was a phase IV, prospective, randomized, open-label, active-controlled, 12-month, two-arm, multicenter study. Treatment-naïve patients with visual impairment (19-73 letters) caused by ME, defined as central subfield thickness (CSFT) > 300 µm, due to BRVO were randomly assigned to ranibizumab monotherapy (n = 29) or combination therapy (ranibizumab + focal/grid short-pulse laser, n = 30). The primary endpoint was the number of ranibizumab injections. Secondary endpoints were mean changes in best-corrected visual acuity (BCVA) and CSFT, and safety. There were no statistically significant differences in the mean number of ranibizumab injections between monotherapy (4.3 injections) vs. combination (4.1 injections) therapy, or in CSFT. BCVA improvement in the monotherapy arm (22.0 letters) was better than the combination therapy arm (15.0 letters) (p = 0.035). Overall, both regimens appeared to be safe and well tolerated. One + PRN ranibizumab is safe and efficacious in treatment-naïve patients with ME secondary to BRVO. A conjunctive laser treatment did not lead to better functional outcomes or fewer ranibizumab injections.

Indexed as

AgedCombined Modality TherapyFemaleHumansIntravitreal InjectionsLaser TherapyMacular EdemaMaleMiddle AgedRanibizumabRetinal Vein OcclusionTreatment OutcomeVisual AcuityRanibizumab

Identifiers

PMID33436683
PMCPMC7804316
OpenAlexW3119603059

What OpenQuestion holds

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LicenceCC BY
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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.