Prophylactic Intraoperative Adjuvant Therapy with 5-Fluorouracil and Low Molecular Weight Heparin for the Prevention of Proliferative Vitreoretinopathy (PVR) in High-risk Patients with Primary Rhegmatogenous Retinal Detachment.
使用 5-氟尿嘧啶和低分子量肝素进行预防性术中辅助治疗,用于预防原发性孔源性视网膜脱离高危患者的增殖性玻璃体视网膜病变 (PVR)。
基本信息
- 批准号:264589742
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:德国
- 项目类别:Clinical Trials
- 财政年份:2015
- 资助国家:德国
- 起止时间:2014-12-31 至 2020-12-31
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
Proliferative vitreoretinopathy (PVR) is the major cause for postoperative failure after surgery for rhegmatogenous retinal detachment (RRD). Fibrovascular scars lead to secondary retinal detachments, which often require multiple extensive operations to achieve re-attachment. Despite advances in the surgical management of PVR, the visual prognosis is poor and many patients become legally blind. Although several studies using chemotherapeutic agents have been undertaken, so far there is no standard therapy to prevent PVR. Two independent trials used an intravitreal infusion with 5-Fluorouracil (5-FU) plus low molecular weight heparin (LMWH) during surgery once in high-risk patients and once in unselected patients. In high-risk patients 5-FU + LMWH reduced PVR rates by 50%, while in unselected patients it did not. A review of the COCHRANE-collaboration led to the recommendation to conduct a clinical randomized trial using 5-FU + LMWH in high-risk patients. We have established non-invasive laser flare photometry as a novel tool for fast and precise estimation of the risk for PVR re-detachments. By selecting high-risk patients with this method we plan to use intraoperative intravitreal 5-FU + LMWH as a prophylactic therapy in a placebo controlled, randomized, double blind trial. We aim to reduce the incidence of PVR in the treatment group. 5-FU + LMWH would be the first effective prophylactic standard treatment to prevent PVR and decrease the incidence of blindness in patients with retinal detachments. Laser flare photometry would limit the treatment to those at high risk.
视网膜脱离(RRD)术后复发的主要原因是玻璃体视网膜病变(PVR)。纤维血管瘢痕导致继发性视网膜脱离,这通常需要多次广泛的手术来实现重新附着。尽管PVR的手术治疗取得了进展,但视力预后很差,许多患者成为法定失明。虽然已经进行了几项使用化疗药物的研究,但到目前为止还没有预防PVR的标准疗法。两项独立的试验在手术过程中使用了5-氟尿嘧啶(5-FU)联合低分子量肝素(LMWH)玻璃体内输注,一次用于高危患者,一次用于高危患者。在高危患者中,5-FU + LMWH可使PVR发生率降低50%,而在高危患者中则不然。对COCHRANE合作的审查导致建议在高风险患者中使用5-FU + LMWH进行临床随机试验。我们已经建立了非侵入性激光闪光光度法作为一种新的工具,用于快速和准确地估计PVR再检测的风险。通过使用这种方法选择高风险患者,我们计划在安慰剂对照、随机、双盲试验中使用术中玻璃体内5-FU + LMWH作为预防性治疗。我们的目的是降低治疗组中PVR的发生率。5-FU + LMWH将是预防PVR和降低视网膜脱离患者失明发生率的第一个有效的预防性标准治疗。激光闪光光度法将治疗限制在高危人群中。
项目成果
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Privatdozentin Dr. Friederike Schaub, since 8/2019其他文献
Privatdozentin Dr. Friederike Schaub, since 8/2019的其他文献
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