Double-masked prospective ocular safety study of a lens epithelial cell antibody to prevent posterior capsule opacification
Double-masked prospective ocular safety study of a lens epithelial cell antibody to prevent posterior capsule opacification
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DOI：
10.1016/s0886-3350(00)00326-6
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发表时间：
2000-05-01
影响因子：
2.8
通讯作者：
Sanguinetti, G
中科院分区：
文献类型：
--
作者：
Meacock, WR;Spalton, DJ;Sanguinetti, G
目的：目的：评价用于预防人类后囊膜混浊（PCO）的免疫偶联物（MDX-RA）的眼内安全性。设置：英国伦敦圣托马斯医院眼科。方法：26例患者接受了超声乳化白内障吸除术和眼内透镜（IOL）植入术。所有患者在手术结束时随机分配接受0.1 mL安慰剂或0.1 mL免疫毒素MDX-RA前房内注射。测试了两种剂量的药物：8名患者使用低剂量（50个单位），9名患者使用高剂量（100个单位），9名患者使用安慰剂。第1、14、30、60、90和180天的随访包括通过糖尿病视网膜病变早期治疗研究测试测量的视力、对比敏感度、房水闪光、IOL前表面的角膜内皮显微镜检查和角膜内皮计数。从后囊的后照明图像测量PCO的面积百分比。结果：毒素治疗的患者角膜内皮细胞计数没有减少。毒素治疗的患者术后早期闪光、前房细胞计数和角膜厚度较高。1年时，该组PCO的中位面积百分比为32.0，低剂量组为3.8，高剂量组为7.4（P = 0.06）。结论：这项前瞻性、随机、安慰剂对照试验证实了MDX-RA用于眼内使用是安全的。对预防PCO的进一步临床试验具有潜在价值。白内障屈光手术杂志2000;26：716-721（C）2000 ASCRS和ESCRS。
Purpose: To evaluate the intraocular safety of an immunoconjugate (MDX-RA) developed to prevent posterior capsule opacification (PCO) in human eyes.Setting: St. Thomas's Hospital Eye Department, London, United Kingdom.Methods: Twenty-six patients had phacoemulsification and implantation of an intraocular lens (IOL). All were randomly allocated at the end of surgery to receive a 0.1 mL placebo or 0.1 mL of the immunotoxin MDX-RA intracamerally. Two doses of the drug were tested: 8 patients with a low dose (50 units), 9 patients with a high dose (100 units), and 9 with placebo. Follow-up at days 1, 14, 30, 60, 90, and 180 consisted of visual acuity measured by the Early Treatment of Diabetic Retinopathy Study test, contrast sensitivity, aqueous flare, specular microscopy of the IOL's anterior surface, and corneal endothelial counts. The percentage area of PCO was measured from retroillumination images of the posterior capsule.Results: There was no decrease in corneal endothelial cell count in toxin-treated patients. Early postoperative flare, anterior chamber cell count, and corneal pachymetry were higher in toxin-treated patients. The median percentage area of PCO at 1 year was 32.0 in the group, 3.8 in the low-dose group, and 7.4 in the high-dose group (P = .06).Conclusion: This prospective, randomized, placebo-controlled trial confirmed that MDX-RA is safe for intraocular use and is of. potential value for further Clinical trials of the prevention of PCO. J. Cataract Refract Surg 2000;26:716-721 (C) 2000 ASCRS and ESCRS.