AGE-RELATED MACULAR DEGENERATION PREVENTION TRIAL

年龄相关性黄斑变性预防试验

• 批准号: 6847911
• 负责人: STUART L FINE
• 金额: $ 14.09万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-07 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6847911
• 关键词: atrophy; biomarker; clinical research; clinical trials; computer data analysis; cooperative study; disease /disorder prevention /control; eye disorder diagnosis; eye fundus photography; eye laser surgery; human middle age (35-64); human old age (65+); human subject; human therapy evaluation; longitudinal human study; macular degeneration; macular drusen; medical complication; nonsurgical revascularization; outcomes research; quality of life; retina detachment; retinal pigment epithelium; vision tests; visual fields; visual perception

Age-related macular degeneration (AMD) is the leading cause of blindness among adults in the United States and several Western countries. Approximately 90% of the blindness is attributable to the neovascular form of AMD and the remainder is attributable to pigment epithelial detachment and geographic atrophy. The Macular Photocoagulation Study has shown that laser treatment is effective in reducing the extent of vision loss in eyes with neovascular AMD. However, most lesions are not amenable to laser treatment and even with treatment visual acuity deteriorates to an average of 20/250 to 20/320. There are no other proven treatments for the advance forms of AMD. Prevention of vision loss from the advanced forms of AMD would have profound public health implications. If an intervention were only 30% effective in preventing choroidal neovascularization (CNV) within the high-risk population, the rate of legal blindness from AMD could be cut in half. The presence of large drusen in the macula is a strong predictor of the development of CNV. Low intensity laser treatment causes high-risk drusen to disappear in most eyes. Controlled, pilot, clinical trials on the effect of laser treatment on development of CNV and loss of vision are underway on two groups of patients: patients with bilateral large drusen and patients with unilateral CNV and the second (fellow) eye with large drusen. Initial reports provide evidence of an increased rate of CNV in treatment fellow eyes, at lest for the first year after treatment. For eyes of patients with bilateral drusen, two small clinical trials show evidence of decreased CNV and better vision in treated eyes at 3 years and one large trial shows little difference between treated and untreated eyes through 18 months. The large segment of the population that might benefit, or be harmed, by laser treatment mandates a thorough evaluation of the treatment. We propose the Complications of Age-related Macular Degeneration Prevention Trial (CAPT) to assess the safety and effectiveness of laser treatment in preventing loss of vision among patients with bilateral drusen. Change in visual acuity will be the primary outcome variable. Secondary outcome measures will be the incidence of CNV, pigment epithelial detachment and geographic atrophy, change in contrast threshold, and change in critical point size for reading. In addition, the participating patients will be described with by their scores on both general and vision specific quality of life assessments.

与年龄有关的黄斑变性（AMD）是失明的主要原因 在美国和几个西方国家的成年人中。 大约90％的失明归因于新生血管形式 AMD和其余的归因于色素上皮脱离 和地理萎缩。黄斑光凝研究表明 激光治疗可有效降低眼睛的视力丧失程度 与新生血管AMD。但是，大多数病变不适合激光 治疗，即使视力敏锐度也会恶化至平均 20/250至20/320。没有其他可靠的进步治疗 AMD的形式。 预防AMD先进形式的视力丧失将会 深远的公共卫生影响。如果干预仅为30％ 有效预防脉络膜新生血管形成（CNV） 高风险人口，AMD的法律失明率可能会降低 一半。黄斑中大drusen的存在是强大的预测指标 CNV的发展。低强度激光处理会导致高风险 drusen在大多数眼睛中消失。受控的，试点，临床试验 激光治疗对CNV发展和视力丧失的影响是 两组患者正在进行中：双侧大drusen患者 和单侧CNV和第二个（同伴）的患者 德鲁森。初始报告提供了CNV率提高的证据 治疗同胞，以免治疗后的第一年。为了 双侧drusen患者的眼睛，两项小型临床试验显示 CNV减少和在3年中治疗的眼睛中更好的视力的证据 一项大型试验显示的眼睛和未治疗的眼睛几乎没有区别 到18个月。 可能受益或受到损害的大部分人口 激光治疗要求对治疗进行彻底评估。我们 提出与年龄相关的黄斑变性的并发症 试验（上尉）评估激光治疗的安全性和有效性 防止双侧drusen患者的视力丧失。更改 视敏度将是主要结果变量。次要结果 措施将是CNV，色素上皮脱离的发生率和 地理萎缩，对比阈值的变化以及关键的变化 读数的点大小。此外，参与的患者将是 通过他们的一般和视觉特定质量的分数来描述 生活评估。