RADIATION AND AMD PLANNING GRANT

继发于老年性黄斑变性(AMD)的脉络膜新生血管(CNV)是65岁及以上美国人致盲的主要原因。激光光凝是唯一被证实的治疗方法，只适用于一小部分患有CNV的眼睛。即使接受激光治疗，平均最终视力也是20/250-20/320。目前尚无有效的治疗方法可预防继发性黄斑变性(CNV)。自首次报道使用外照射治疗新生血管以来，许多未控制病例的治疗结果已被报道，该方法已在一些地区被作为标准治疗。由于很大一部分人群可能从放射治疗中受益或受到伤害，因此有必要对放射治疗进行一项随机对照研究。在本申请中，我们请求支持规划一项多中心临床试验，即年龄相关性黄斑变性和辐射试验(AMDRT)，以评估放射治疗在预防CNV导致的视觉功能丧失方面的安全性和有效性。这项多中心随机临床试验的具体目标是：1.评估针对继发于年龄相关性粘膜变性的未经治疗的中心凹下新生血管的放射治疗(新的中心凹下CNV子研究)；2.评估对接受过激光治疗但荧光素血管造影术显示渗漏的CNV病变的放射治疗(复发性CNV子研究)；3.评估辅助放射治疗以防止激光光凝治疗患者因复发的CNV而视力下降(复发预防子研究)。在本申请所涵盖的时间段内要完成的具体目标是：1.进一步改进AMDRT的设计，特别注意假治疗的可行性和建议的辐射剂量的短期副作用；2.为AMDRT准备一份完整的操作手册；3.完善AMDRT协调中心、阅读中心和放射物理中心的程序；4.准备AMDRT中心资源中心和临床中心的拨款申请。

Choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) is the leading cause of blindness among Americans aged 65 and over. Laser photocoagulation, the only proven treatment, is applicable to only a small subset of eyes with CNV. Even with laser treatment, the average final visual acuity is 20/250-20/320. There are no proven treatments for prevention of (CNV) secondary to AMD. Since the first report of the use of external beam radiation for the treatment of CNV, the results of many uncontrolled case series have been reported and the procedure has been adopted as a standard treatment in some areas. Due to the large segment of the population that might benefit, or be harmed, by radiation treatment, a controlled randomized study of radiation therapy is warranted. In this application, we request support for the planning of a multicenter clinical trial, the Age-related Macular Degeneration and Radiation Trial (AMDRT), to assess the safety and effectiveness of radiation treatment in preventing the loss of visual function due to CNV. The specific aims of the multicenter, randomized clinical trial are to: 1. Evaluate radiation treatment for previously untreated subfoveal neovascularization secondary to age-related mucular degeneration (New Subfoveal CNV Substudy); 2. Evaluate radiation treatment for CNV lesions which have been treated with laser but show leakage on fluorescein angiography (Recurrent CNVSubstudy); 3. Evaluate adjuvant radiation treatment to prevent visual acuity loss from recurrent CNV in patients treated with laser photocoagulation (Recurrence Prevention Substudy). The specific aims to be accomplished during the time period covered by this application are to: 1. Further refine the design of the AMDRT, with particular attention to the feasibility of sham treatment and the short-term side effects of the proposed dose of radiation; 2. Prepare a complete manual of operations for the AMDRT; 3. Refine procedures for the AMDRT Coordinating Center, Reading Centers, and Radiological Physics Center; 4. Prepare grant applications for the AMDRT central resource centers and clinical centers.