Microplasmin Intravitreal Administration in Patients with Vitreomacular Traction Scheduled for Vitrectomy The MIVI I Trial
Microplasmin Intravitreal Administration in Patients with Vitreomacular Traction Scheduled for Vitrectomy The MIVI I Trial
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DOI：
10.1016/j.ophtha.2009.03.051
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发表时间：
2009-07-01
期刊：
影响因子：
13.7
通讯作者：
Kampik, Anselm
中科院分区：
文献类型：
--
作者：
de Smet, Marc D.;Gandorfer, Arnd;Kampik, Anselm
目的：评价玻璃体内微纤溶酶在玻璃体黄斑牵引性黄斑病变玻璃体切除术前给予4个剂量和几个暴露时间的安全性和初步疗效。设计：一项多中心、前瞻性、非对照、剂量递增、I/II期临床试验。参与者：60例患者入组6个连续队列。干预：4个剂量中的1个剂量的微纤溶酶的单次玻璃体内注射（100 μ l中25、50、75或125 μ g）在计划的睫状体平坦部玻璃体切除术前1至2小时、24小时或7天给药。对于安全性，完整的眼科检查，眼底照相，荧光素血管造影，Humphrey视野和电生理;对于有效性，通过B扫描超声评估玻璃体后脱离（PVD）诱导和玻璃体切除术时PVD诱导的容易性。结果：随着暴露时间的增加，微纤溶酶的使用导致超声检查PVD诱导的发生率逐渐升高。在0、2和5名患者中，随着暴露量的增加（2小时、24小时、7天），用25 μ g微纤溶酶观察到手术前PVD。随着剂量的增加，通过超声观察到手术前的PVD如下：25 μ g，0; 50 μ g，1; 75 μ g，2; 125 μ g，3。然而，在手术中，使用125 μ g剂量，这些患者的视网膜表面上存在不连续的玻璃体层，这是由于玻璃体劈裂形式的异常PVD的诱导。1例视网膜脱离在给予微纤溶酶后不久发生。两个在手术后发展。有没有其他的安全性concerns.Conclusions：从这个初步的临床试验评估玻璃体内microplasmin的结果显示，药物耐受性良好，并能够诱导药理学PVD在一些患者。这些结果保证了在较大的对照试验中对微纤溶酶的评估。财务披露：在参考文献之后可以找到专有或商业披露。Ophthalmology 2009; 116：1349 - 1355（C）2009，美国眼科学会。
Purpose: To evaluate the safety and preliminary efficacy of 4 doses and several exposure times of intravitreal microplasmin given before pars plana vitrectomy for vitreomacular traction maculopathy.Design: A multicenter, prospective, uncontrolled, dose-escalation, phase I/II clinical trial.Participants: Sixty patients enrolled into 6 successive cohorts.Intervention: A single intravitreal injection of microplasmin at 1 of 4 doses (25, 50, 75, or 125 mu g in 100 mu l) administered either 1 to 2 hours, 24 hours, or 7 days before planned pars plana vitrectomy.Main Outcome Measures: For safety, a complete ophthalmologic examination, fundus photography, fluorescein angiography, Humphrey visual fields, and electrophysiology; for efficacy, posterior vitreous detachment (PVD) induction as assessed by B-scan ultrasound and ease of PVD induction at the time of vitrectomy.Results: The use of microplasmin led to a progressively higher incidence of PVD induction on ultrasonography with increasing time exposure. A PVD before surgery was observed with 25 mu g microplasmin in 0, 2, and 5 patients with increasing exposures (2 hours, 24 hours, 7 days). With increasing dose, a PVD before surgery was observed by ultrasound as follows: 25 mu g, 0; 50 mu g, 1; 75 mu g, 2; 125 mu g, 3. However, at surgery, with a 125-mu g dose, these patients had a discontinuous layer of vitreous present on the retinal surface resulting from the induction of an anomalous PVD in the form of vitreoschisis. One retinal detachment developed shortly after administration of microplasmin. Two developed after surgery. There were no other safety concerns.Conclusions: Results from this initial clinical trial evaluating intravitreal microplasmin show the drug to be well tolerated and capable of inducing a pharmacologic PVD in some patients. These results warrant evaluation of microplasmin in larger, controlled trials.Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2009; 116:1349 -1355 (C) 2009 by the American Academy of Ophthalmology.