Mizuno Yu, Komatsu Kaori, Tokumo Kana, Okada Naoki, Onoe Hiromitsu, Okumichi Hideaki, Hirooka Kazuyuki, Miura Yukiko, Kiuchi Yoshiaki
Department of Ophthalmology and Visual Science, Hiroshima University, 1-2-3 Kasumi Minamiku, Hiroshima, 734-8551, Japan.
Hiroshima Eye Clinic, 13-4, Noborimachi Nakaku, Hiroshima, 730-0016, Japan.
Contemp Clin Trials Commun. 2023 Jun 4;33:101160. doi: 10.1016/j.conctc.2023.101160. eCollection 2023 Jun.
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.
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.
We plan to establish the safety of ripasudil and to collect information involving the efficacy of ripasudil widely in this study.
小梁切除术后滤过泡失败行针刺术后，尚无维持或降低眼压的确切方法。关于新型抗高血压药物，ripasudil是一种Rho相关蛋白激酶抑制剂眼药水，在体外能够预防过度瘢痕形成。本研究旨在评估青光眼患者行针刺术后使用ripasudil预防术后瘢痕形成的安全性。我们还通过抑制滤过泡纤维化来研究ripasudil对滤过泡失败针刺术后的疗效。
本研究是一项多中心、开放标签、单臂II期试验，旨在评估ripasudil对青光眼患者针刺术后的安全性和疗效。广岛大学医院和广岛眼科诊所将招募40例小梁切除术后至少3个月将接受针刺术的患者。所有患者在针刺术后每天滴注ripasudil两次，持续三个月。主要终点是ripasudil的安全性。
我们计划在本研究中确定ripasudil的安全性，并广泛收集有关ripasudil疗效的信息。
