Evidence map›Paper›PMID 34315793›Full record

ArticleBMJ open2021

Study protocol for a multicentre, open-label, single-arm phase I/II trial to evaluate the safety and efficacy of ripasudil 0.4% eye drops for retinopathy of prematurity.

Mitsuru Arima, Hirosuke Inoue, Shintaro Nakao, Akiko Misumi, Maya Suzuki, Itsuka Matsushita, Shunsuke Araki, Chiemi Yamashiro, Kazumasa Takahashi, Masayuki Ochiai and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04621136 (PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 43% 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.

NCT04621136 phase1 / phase2completednot on this map

PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity

TypeinterventionalSponsorKyushu UniversityRan2020 to 2022Enrolled24ConditionsRetinopathy of PrematurityArmsRipasudil ophthalmic solution 0.4%
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. A human-specificMolecular therapy. Nucleic acids · 2025
    Article
  3. 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

20 authors at 5 institutions in 1 country.

Mitsuru ArimaOphthalmology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan m-arima@eye.med.kyushu-u.ac.jp.ORCID 0000-0002-6081-8133
Hirosuke InouePediatrics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Shintaro NakaoOphthalmology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID 0000-0003-4200-0052
Akiko MisumiCenter for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Maya SuzukiCenter for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Itsuka MatsushitaOphthalmology, University of Occupational and Environmental Health, Kitakyushu, Japan.
Shunsuke ArakiPediatrics, University of Occupational and Environmental Health, Kitakyushu, Japan.
Chiemi YamashiroOphthalmology, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Kazumasa TakahashiPediatrics, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Masayuki OchiaiPediatrics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Noriko YoshidaOphthalmology, Fukuoka Dental College, Fukuoka, Japan.
Masayuki HiroseCenter for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Junji KishimotoCenter for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Koji TodakaCenter for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Shunji HasegawaPediatrics, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Kazuhiro KimuraOphthalmology, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Koichi KusuharaPediatrics, University of Occupational and Environmental Health, Kitakyushu, Japan.
Hiroyuki KondoOphthalmology, University of Occupational and Environmental Health, Kitakyushu, Japan.
Shouichi OhgaPediatrics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Koh-Hei SonodaOphthalmology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kyushu University · JPKyushu University Hospital · JPUniversity of Occupational and Environmental Health Japan · JPYamaguchi University · JPFukuoka Dental College · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRetinopathy of prematurity (ROP) is a vascular proliferative disorder that occurs in preterm infants. Existing treatments are only indicated in severe ROP cases due to the high invasiveness and the potential risk of irreversible side effects. We previously elucidated that ripasudil, a selective inhibitor of the Rho-associated protein kinase, has the ability to inhibit abnormal retinal neovascularisation in animal models. In addition, ripasudil eye drops (Glanatec ophthalmic solution 0.4%) have been already used for the treatment of glaucoma. Since eye drop therapy is less invasive, early intervention for ROP is possible. The purpose of this phase I/II trial is to evaluate the safety and efficacy of ripasudil eye drops for preterm infants with ROP. METHODS AND ANALYSIS: This is a multicentre, open-label, single-arm phase I/II trial. To evaluate the safety and efficacy of ripasudil as much as possible, ripasudil will be administered to all enrolled preterm infants with zone I/II, stage 1, or worse ROP. The safety and efficacy of ripasudil in treated patients will be assessed in comparison to a historical control group. Because this is the first trial of ripasudil in preterm infants, a dose-escalation study (once daily for 1 week, then two times per day for 2 weeks) will be conducted in phase I. After obtaining approval from the independent data and safety monitoring board to continue the trial after the completion of phase I, phase II will be conducted. In phase II, ripasudil eye drops will be administered two times per day for 12 weeks. The primary endpoint in phase II is also safety. Efficacy and pharmacokinetics will be evaluated as secondary endpoints. ETHICS AND DISSEMINATION: This study protocol was approved by the institutional review board at each of the participating centres. Data will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: NCT04621136 and jRCT2071200047.

Indexed as

Retinopathy of PrematurityAnimalsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicHumansInfantInfant, NewbornInfant, PrematureIsoquinolinesMulticenter Studies as TopicOphthalmic SolutionsSulfonamidesTreatment OutcomeIsoquinolinesK-115Ophthalmic SolutionsSulfonamidesophthalmologypaediatric ophthalmologypaediatricsvascular medicinevetreoretinal

Identifiers

PMID34315793
PMCPMC8317081
OpenAlexW3184139245

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.