A multicenter phase II study on the safety of rho-kinase inhibitor (ripasudil) with needling for the patients after trabeculectomy
Background: There is no established method of maintaining or reducing intra ocular pressure after the needling procedure for failing blebs post trabeculectomy. Regarding newer antihypertensive medications, ripasudil, which is a rho-associated protein kinase inhibitor ophthalmic solution, was able to...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-06-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865423001060 |
| _version_ | 1797799954091081728 |
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| author | Yu Mizuno Kaori Komatsu Kana Tokumo Naoki Okada Hiromitsu Onoe Hideaki Okumichi Kazuyuki Hirooka Yukiko Miura Yoshiaki Kiuchi |
| author_facet | Yu Mizuno Kaori Komatsu Kana Tokumo Naoki Okada Hiromitsu Onoe Hideaki Okumichi Kazuyuki Hirooka Yukiko Miura Yoshiaki Kiuchi |
| author_sort | Yu Mizuno |
| collection | DOAJ |
| description | Background: There is no established method of maintaining or reducing intra ocular pressure after the needling procedure for failing blebs post trabeculectomy. Regarding newer antihypertensive medications, ripasudil, which is a rho-associated protein kinase inhibitor ophthalmic solution, was able to prevent excessive scarring in vitro. This study aims to evaluate the safety of glaucoma patients submitted to the needling procedure and administered ripasudil for preventing scarring after the procedure. We also investigate the efficacy of ripasudil after needling for bleb failure through suppression of fibrosis to the bleb. Methods: This study is a multicenter, open-label, single-arm, phase II trial to evaluate the safety and efficacy of ripasudil in glaucoma patients after the needling procedure. Forty patients who will undergo needling at least 3 months after trabeculectomy will be recruited in Hiroshima university hospital and Hiroshima eye clinic. All the patients will instill ripasudil two times per day for three months after the needling procedure. The primary endpoint is the safety of ripasudil. Conclusions: We plan to establish the safety of ripasudil and to collect information involving the efficacy of ripasudil widely in this study. |
| first_indexed | 2024-03-13T04:27:21Z |
| format | Article |
| id | doaj.art-d3ddb02e6836432d94568db18fba45d5 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-03-13T04:27:21Z |
| publishDate | 2023-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-d3ddb02e6836432d94568db18fba45d52023-06-20T04:20:25ZengElsevierContemporary Clinical Trials Communications2451-86542023-06-0133101160A multicenter phase II study on the safety of rho-kinase inhibitor (ripasudil) with needling for the patients after trabeculectomyYu Mizuno0Kaori Komatsu1Kana Tokumo2Naoki Okada3Hiromitsu Onoe4Hideaki Okumichi5Kazuyuki Hirooka6Yukiko Miura7Yoshiaki Kiuchi8Department of Ophthalmology and Visual Science, Hiroshima University, 1-2-3 Kasumi Minamiku, Hiroshima, 734-8551, Japan; Corresponding author.Department of Ophthalmology and Visual Science, Hiroshima University, 1-2-3 Kasumi Minamiku, Hiroshima, 734-8551, JapanDepartment of Ophthalmology and Visual Science, Hiroshima University, 1-2-3 Kasumi Minamiku, Hiroshima, 734-8551, JapanDepartment of Ophthalmology and Visual Science, Hiroshima University, 1-2-3 Kasumi Minamiku, Hiroshima, 734-8551, JapanDepartment of Ophthalmology and Visual Science, Hiroshima University, 1-2-3 Kasumi Minamiku, Hiroshima, 734-8551, JapanDepartment of Ophthalmology and Visual Science, Hiroshima University, 1-2-3 Kasumi Minamiku, Hiroshima, 734-8551, JapanDepartment of Ophthalmology and Visual Science, Hiroshima University, 1-2-3 Kasumi Minamiku, Hiroshima, 734-8551, JapanHiroshima Eye Clinic, 13-4, Noborimachi Nakaku, Hiroshima, 730-0016, JapanDepartment of Ophthalmology and Visual Science, Hiroshima University, 1-2-3 Kasumi Minamiku, Hiroshima, 734-8551, JapanBackground: There is no established method of maintaining or reducing intra ocular pressure after the needling procedure for failing blebs post trabeculectomy. Regarding newer antihypertensive medications, ripasudil, which is a rho-associated protein kinase inhibitor ophthalmic solution, was able to prevent excessive scarring in vitro. This study aims to evaluate the safety of glaucoma patients submitted to the needling procedure and administered ripasudil for preventing scarring after the procedure. We also investigate the efficacy of ripasudil after needling for bleb failure through suppression of fibrosis to the bleb. Methods: This study is a multicenter, open-label, single-arm, phase II trial to evaluate the safety and efficacy of ripasudil in glaucoma patients after the needling procedure. Forty patients who will undergo needling at least 3 months after trabeculectomy will be recruited in Hiroshima university hospital and Hiroshima eye clinic. All the patients will instill ripasudil two times per day for three months after the needling procedure. The primary endpoint is the safety of ripasudil. Conclusions: We plan to establish the safety of ripasudil and to collect information involving the efficacy of ripasudil widely in this study.http://www.sciencedirect.com/science/article/pii/S2451865423001060GlaucomaTrabeculectomyNeedlingA rho-associated protein kinase inhibitorRipasudil |
| spellingShingle | Yu Mizuno Kaori Komatsu Kana Tokumo Naoki Okada Hiromitsu Onoe Hideaki Okumichi Kazuyuki Hirooka Yukiko Miura Yoshiaki Kiuchi A multicenter phase II study on the safety of rho-kinase inhibitor (ripasudil) with needling for the patients after trabeculectomy Contemporary Clinical Trials Communications Glaucoma Trabeculectomy Needling A rho-associated protein kinase inhibitor Ripasudil |
| title | A multicenter phase II study on the safety of rho-kinase inhibitor (ripasudil) with needling for the patients after trabeculectomy |
| title_full | A multicenter phase II study on the safety of rho-kinase inhibitor (ripasudil) with needling for the patients after trabeculectomy |
| title_fullStr | A multicenter phase II study on the safety of rho-kinase inhibitor (ripasudil) with needling for the patients after trabeculectomy |
| title_full_unstemmed | A multicenter phase II study on the safety of rho-kinase inhibitor (ripasudil) with needling for the patients after trabeculectomy |
| title_short | A multicenter phase II study on the safety of rho-kinase inhibitor (ripasudil) with needling for the patients after trabeculectomy |
| title_sort | multicenter phase ii study on the safety of rho kinase inhibitor ripasudil with needling for the patients after trabeculectomy |
| topic | Glaucoma Trabeculectomy Needling A rho-associated protein kinase inhibitor Ripasudil |
| url | http://www.sciencedirect.com/science/article/pii/S2451865423001060 |
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