Comprehensive combined analysis of physician-initiated phase II and III clinical trials on a cultured human corneal endothelial cell product for treating bullous keratopathy.

IF 2.1 3区 医学 Q2 OPHTHALMOLOGY Japanese Journal of Ophthalmology Pub Date : 2024-10-02 DOI:10.1007/s10384-024-01123-w
Morio Ueno, Kojiro Imai, Yasufumi Tomioka, Go Horiguchi, Takanori Kameda, Satoshi Teramukai, Akitaka Tsujikawa, Tsutomu Inatomi, Chie Sotozono, Shigeru Kinoshita
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Abstract

To evaluate the efficacy and safety of a cultured human corneal endothelial cell (cHCEC) product in eyes with bullous keratopathy (BK). Combined analysis of multicenter phase II and III clinical trials. This analysis involved 15 BK eyes in the phase II trial and 12 BK eyes in the phase III trial that underwent cHCEC transplant therapy. Safety was assessed in all the cases. Efficacy was assessed in 17 cases with exclusion of the low- and medium-dose groups in the phase II trial. The primary endpoint was a corneal endothelial cell density of 1000 cells/mm2 or more at 24 weeks post-transplant, which was attained in 94.1% of the eyes (16 of 17), with a 95% CI of 71.3-99.9%. Additionally, 82.4% of the eyes (14 of 17) met the secondary endpoint of reduction in corneal thickness to less than 630 µm without corneal epithelial edema within the same time frame, with a 95% CI of 56.6-96.2%. The mean decrease in corneal thickness from baseline to 24 weeks post-transplant was -187.4 µm (95% CI, -240.2 µm to -134.5 µm). Furthermore, all the eyes exhibited improvement in best-corrected visual acuity from baseline to 24 weeks post-transplant (95% CI, 80.5-100.0%). By 24 weeks post-transplant, 88.9% of the patients (24 of 27) had experienced adverse events, which were mostly local, mild, and transient. The cHCEC product of this study reconstitutes the corneal endothelial layer with high cellular density and restores corneal thickness and improves visual acuity.

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对医生发起的治疗大疱性角膜病的培养人角膜内皮细胞产品的 II 期和 III 期临床试验进行全面综合分析。
评估培养人角膜内皮细胞(cHCEC)产品对牛皮状角膜病(BK)患者的疗效和安全性。对多中心 II 期和 III 期临床试验进行综合分析。该分析涉及 15 只接受过 cHCEC 移植治疗的 II 期试验 BK 眼和 12 只接受过 cHCEC 移植治疗的 III 期试验 BK 眼。对所有病例进行了安全性评估。对 17 例病例进行了疗效评估,并排除了 II 期试验中的低剂量组和中等剂量组。主要终点是移植后24周时角膜内皮细胞密度达到或超过1000个/平方毫米,94.1%的眼睛(17例中的16例)达到了这一目标,95% CI为71.3-99.9%。此外,82.4%的眼睛(17 只眼睛中的 14 只)达到了次要终点,即在同一时间内角膜厚度减少到小于 630 微米且无角膜上皮水肿,95% CI 为 56.6%-96.2%。从基线到移植后24周,角膜厚度的平均降幅为-187.4微米(95% CI,-240.2微米至-134.5微米)。此外,从基线到移植后24周,所有眼睛的最佳矫正视力都有所提高(95% CI,80.5%-100.0%)。到移植后 24 周,88.9% 的患者(27 例中的 24 例)出现了不良反应,这些不良反应大多是局部的、轻微的和短暂的。本研究的 cHCEC 产品能以高细胞密度重建角膜内皮层,恢复角膜厚度并提高视力。
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来源期刊
CiteScore
4.80
自引率
8.30%
发文量
65
审稿时长
6-12 weeks
期刊介绍: The Japanese Journal of Ophthalmology (JJO) was inaugurated in 1957 as a quarterly journal published in English by the Ophthalmology Department of the University of Tokyo, with the aim of disseminating the achievements of Japanese ophthalmologists worldwide. JJO remains the only Japanese ophthalmology journal published in English. In 1997, the Japanese Ophthalmological Society assumed the responsibility for publishing the Japanese Journal of Ophthalmology as its official English-language publication. Currently the journal is published bimonthly and accepts papers from authors worldwide. JJO has become an international interdisciplinary forum for the publication of basic science and clinical research papers.
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