Evidence map›Paper›PMID 40202692›Full record

Trial reportJapanese journal of ophthalmology2025

Efficacy and safety of ROH-101 (0.15% ganciclovir gel) for cytomegalovirus corneal endotheliitis: an open-label, uncontrolled, phase 3 study in Japan.

Noriko Koizumi, Dai Miyazaki, Seiichiro Sugita, Chie Sotozono, Tsutomu Inatomi, Hiroshi Goto, Atsushi Shiraishi, Shuichiro Eguchi, Shin-Ichiro Ito, Yuichi Hori and 6 more

Abstract readMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Japanese journal of ophthalmology, 2025. 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. Review
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

16 authors.

Noriko KoizumiDepartment of Biomedical Engineering, Faculty of Life and Medical Sciences, Doshisha University, Kyotanabe, Kyoto, 610-0321, Japan. nkoizumi@mail.doshisha.ac.jp.ORCID http://orcid.org/0000-0002-6940-1334
Dai MiyazakiDivision of Ophthalmology and Visual Science, Faculty of Medicine, Tottori University, Tottori, Japan.
Seiichiro SugitaSugita Eye Hospital, Nagoya, Aichi, Japan.
Chie SotozonoDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Tsutomu InatomiDepartment of Ophthalmology, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan.
Hiroshi GotoDepartment of Ophthalmology, Tokyo Medical University, Tokyo, Japan.
Atsushi ShiraishiDepartment of Ophthalmology, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.
Shuichiro EguchiEguchi Eye Hospital, Hakodate, Hokkaido, Japan.
Shin-Ichiro ItoDepartment of Ophthalmology, Kobe City Eye Hospital, Kobe, Hyogo, Japan.
Yuichi HoriDepartment of Ophthalmology, Toho University Graduate School of Medicine, Tokyo, Japan.
Eiichi UchioDepartment of Ophthalmology, Fukuoka University School of Medicine, Fukuoka, Japan.
Takeshi SomaDepartment of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan.
Takeo FukuchiDepartment of Ophthalmology and Visual Science, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Ken HayashiHayashi Eye Hospital, Fukuoka, Japan.
Yusuke TakeuchiRohto Pharmaceutical Co., Ltd., Osaka, Japan.
Yoshitsugu InoueDivision of Ophthalmology and Visual Science, Faculty of Medicine, Tottori University, Tottori, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCytomegalovirus (CMV) corneal endotheliitis often causes severe visual impairment owing to irreversible corneal endothelial dysfunction. Given the side effects of systemic antiviral therapy, development of an approved topical antiviral agent for CMV corneal endotheliitis is desirable. This study evaluated the efficacy and safety of topical 0.15% GCV gel, ROH-101, in the treatment of CMV corneal endotheliitis in Japanese patients. STUDY

designOpen-label, multicenter, uncontrolled, phase 3 study (jRCT2051210064).

methodsThe study was conducted from August 2021 to December 2022, with a 2-week run-in period with 0.1% fluorometholone eye drops alone, a 12-week treatment period with additional ROH-101, and a 24-week post-treatment observation period after discontinuation of ROH-101. The primary endpoint was the proportion of patients achieving a CMV DNA copy number in the aqueous humor of less than 10

resultsTwelve eyes of 12 patients with PCR-proven CMV corneal endotheliitis were enrolled. Treatment was discontinued in 1 eye owing to an adverse event. The other 11 eyes completed 12 weeks of treatment with 63.6% achieving the primary endpoint. The clinical findings, such as corneal edema, coin-shaped lesions, and anterior chamber inflammation, improved in all 11 eyes and did not worsen in 8 eyes that completed the post-treatment observation period. Endothelial cell density was well maintained, and none of the 11 eyes showed corneal endothelial dysfunction. Mild adverse drug reactions were reported in 3 eyes (8.3%).

conclusionROH-101 was a safe and efficacious treatment in Japanese patients diagnosed with CMV corneal endotheliitis.

Indexed as

CytomegalovirusCytomegalovirus InfectionsEndothelium, CornealEye Infections, ViralGanciclovirKeratitisAdultAgedAntiviral AgentsAqueous HumorDNA, ViralDose-Response Relationship, DrugFemaleFollow-Up StudiesGelsHumansAntiviral AgentsDNA, ViralGanciclovirGelsOphthalmic Solutions0.15% ganciclovir gelCMV DNA copy numberCytomegalovirus corneal endotheliitisEfficacy and safetyROH-101

Identifiers

PMID40202692
PMCPMC12003522

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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.