Evidence map›Paper›PMID 39060675›Full record

Trial reportJapanese journal of ophthalmology2024

Safety and efficacy of ripasudil eye drops in preterm infants with retinopathy of prematurity: phase 1/2, open label, single-arm trial.

Mitsuru Arima, Hirosuke Inoue, Akiko Misumi, Shoko Tsukamoto, Itsuka Matsushita, Shunsuke Araki, Manami Ohta, Kazumasa Takahashi, Miyuki Imazato, Tomoko Goto and 19 more

Abstract readMulticenter StudyClinical Trial, Phase IIClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Japanese journal of ophthalmology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

29 authors.

Mitsuru ArimaDepartment of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka, 812-8582, Japan. marima4802@gmail.com.ORCID http://orcid.org/0000-0002-6081-8133
Hirosuke InoueDepartment of Pediatrics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Akiko MisumiCenter for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Shoko TsukamotoDepartment of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka, 812-8582, Japan.
Itsuka MatsushitaDepartment of Ophthalmology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Shunsuke ArakiDepartment of Pediatrics, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Manami OhtaDepartment of Ophthalmology, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
Kazumasa TakahashiDepartment of Pediatrics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
Miyuki ImazatoDepartment of Ophthalmology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Tomoko GotoDepartment of Obstetrics and Gynecology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Yoshinori AokiDivision of Pediatrics, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Koshiro TagawaCenter for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Masayuki HiroseCenter for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Yuito FujitaDepartment of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.
Noriko YoshidaClinical Research Center, Saga University Hospital, Saga, Japan.
Shintaro NakaoDepartment of Ophthalmology, Juntendo University School of Medicine, Tokyo, Japan.
Hiroyuki KondoDepartment of Ophthalmology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Koichi KusuharaDepartment of Pediatrics, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Kazuhiro KimuraDepartment of Ophthalmology, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
Shunji HasegawaDepartment of Pediatrics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
Yasuhiro IkedaDepartment of Ophthalmology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Yuki KodamaDepartment of Obstetrics and Gynecology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Hiroshi MoritakeDivision of Pediatrics, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Masayuki OchiaiDepartment of Pediatrics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Shouichi OhgaDepartment of Pediatrics, Graduate School of Medical Sciences, Kyushu University, 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.
Ichiro IeiriDepartment of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.
Koh-Hei SonodaDepartment of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka, 812-8582, Japan.

Funding

the Japan Agency for Medical Research and Development JP20ek0109458
6 · The paper itself

Abstract

purposeTo assess the safety and efficacy of ripasudil for retinopathy of prematurity (ROP). STUDY

designPhase 1/2, multicenter, open-label, single-arm, 12-week clinical trial.

methodsInfants born with gestational age (GA) of ≤ 32 weeks or weight of ≤ 1500 g with zone I or II, ≥ stage 1, ROP in both eyes were enrolled. Ripasudil eye drops were administered to patients in both eyes. Phase 1 was a dose-escalation study (once daily for 1 week, then twice daily for 2 weeks); an additional dosing up to 9 weeks was allowed if no safety issues occurred. In phase 2, ripasudil was administered twice daily for up to 12 weeks. Adverse events were assessed. The proportion of patients with type 1 ROP progression, number of days for type 1 ROP progression, and progression to the most advanced ROP stage were estimated.

resultsTwenty-four infants were enrolled (phase 1, n = 3; phase 2, n = 21). Nineteen and four patients experienced systemic and ocular adverse events, respectively. Efficacy endpoints were not different between the ripasudil and historical control groups. However, in the GA ≤ 27 weeks subgroup, fewer patients progressed to type 1 ROP in the ripasudil than in the historical control group (P = 0.09). In the GA ≤ 27 weeks subgroups, the 25th percentile for the number of days for type 1 ROP progression was 22 days in the historical control group and 44 days in the ripasudil group.

conclusionRipasudil was safe and inhibited/delayed type 1 ROP progression, especially in infants with short GA.

Indexed as

Gestational AgeInfant, PrematureIsoquinolinesOphthalmic SolutionsRetinopathy of PrematuritySulfonamidesDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansInfantInfant, NewbornMaleTreatment OutcomeIsoquinolinesK-115Ophthalmic SolutionsSulfonamidesDrug repositioningEye dropsPreterm infantsRetinopathy of prematurityRipasudil

Identifiers

PMID39060675

What OpenQuestion 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 OpenQuestion graph.