RADIATION AND AMD PLANNING GRANT

继发于年龄相关性黄斑变性（AMD）的脉络膜新生血管（CNV）是65岁及以上美国人失明的主要原因。 激光光凝是唯一被证实的治疗方法，仅适用于一小部分CNV眼睛。 即使使用激光治疗，平均最终视力也为20/250-20/320。 目前还没有有效的治疗方法来预防继发于AMD的CNV。自从第一次报道使用外照射治疗CNV以来，已经报道了许多未控制病例系列的结果，并且该程序已在某些领域被采用为标准治疗。 由于很大一部分人群可能受益于放射治疗，也可能受到放射治疗的伤害，因此有必要对放射治疗进行随机对照研究。在本申请中，我们请求支持计划一项多中心临床试验，即视网膜相关黄斑变性和放射试验（AMDRT），以评估放射治疗在预防CNV所致视功能丧失方面的安全性和有效性。多中心、随机临床试验的具体目的是：1. 评价先前未治疗的继发于年龄相关性粘液变性的中心凹下新生血管的放射治疗（新中心凹下CNV子研究）; 2. 评价已用激光治疗但在荧光素血管造影显示渗漏的CNV病变的放射治疗（复发性CNV亚研究）; 3. 评价辅助放射治疗对预防激光光凝治疗患者复发CNV视力丧失的作用（复发预防子研究）。在本申请所涵盖的时间段内要实现的具体目标是：1. 进一步完善AMDRT的设计，特别注意假治疗的可行性和拟议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中央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.