NONSURGICAL TREATMENT OF VITREAL HEMORRHAGES

玻璃体出血的非手术治疗

• 批准号: 2020204
• 负责人: HAMPAR KARAGEOZIAN
• 金额: $ 9.51万
• 依托单位: ADVANCED CORNEAL SYSTEMS (ACS)
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-14 至 1998-02-13
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2020204
• 关键词: angiography; drug adverse effect; drug screening /evaluation; enzyme activity; enzyme therapy; extracellular matrix; eye pharmacology; hyaluronidase; immunocytochemistry; injection /infusion; laboratory rabbit; method development; nonhuman therapy evaluation; ophthalmoscopy; pharmacokinetics; retina hemorrhage; vitrectomy

Description: Vitreous hemorrhages diminish vision, may mask retinal detachments and predispose for proliferative vitreoretinopathy. One current treatment removes all or part of the vitreous (vitrectomy) but can be associated wit complications. Clearly, the development of a simple, non-surgical procedure for vitreous hemorrhage would be extremely beneficial. The PI has patented a drug suitable for intravitreal injection which increases the clearance rate of intravitreal blood. FDA approved Phase I safety trials are scheduled to begin. The PI proposes concurrent animal studies. The specific aims are to determine the: 1). Duration of the drug in the vitreous. 2). Changes in the extracellular matrix after drug application. 3). Effects of the drug upon endogenous enzymes. 4). Changes in the retina after drug application. 5). Long term effect of blood and the drug on the retina. The objective is to demonstrate that this drug is a safe, effective alternative to vitrectomy after vitreal hemorrhage. Patient benefits are improved vision, earlier diagnosis and treatment, and decreased risks. As some 640,000 vitreal hemorrhages and 100,000 vitrectomies occur annually, this non-surgical protocol has great clinical and economic significance. PROPOSED COMMERCIAL APPLICATION: This product would be an alternative to surgery and could be used to ameliorate the adverse visual consequences of retinal hemorrhages. This procedure, if proven to be safe and effective, could be lower the cost of care for patients who develop visual problems related to this pathology.

描述：玻璃体出血会降低视力，可能掩盖视网膜 易患增殖性玻璃体视网膜病变。 一 目前的治疗去除全部或部分玻璃体（玻璃体切除术）， 与并发症有关。 显然，开发一个简单的， 玻璃体积血的非手术治疗将是极其 有利于 PI已经获得了一种适用于玻璃体内注射的药物的专利， 增加玻璃体内血液的清除率。 FDA批准的第一阶段 安全性试验计划开始。 主要研究者建议同时使用动物 问题研究 具体目标是确定： 1）。 药物在玻璃体中的持续时间。 2）的情况。 用药后细胞外基质的变化。 （3）第三章。 药物对内源性酶的影响。 4）。 药物应用后视网膜的变化。 5）。 血液和药物对视网膜的长期影响。 目的是证明这种药物是一种安全、有效的 玻璃体出血后玻璃体切除术的替代方法。 患者受益 提高视力，早期诊断和治疗，降低风险。 作为 每年进行约640，000例玻璃体切除术和100，000例玻璃体切除术， 这种非手术方案具有很大的临床和经济意义。 拟定商业应用： 该产品将是手术的替代方案，可用于 改善视网膜病变的不良视觉后果。 这 如果被证明是安全有效的，可以降低成本。 护理与这种病理学相关的视力问题的患者。