AMD Treatment Network Chairman Clinical Study Planning

在美国和大多数发达国家，老年性黄斑变性是导致失明的主要原因。对AMD患者的新治疗方法进行评估的需求是巨大的，并且可能持续许多年。尽管最近有文献证明使用维替泊芬进行光动力治疗（PDT）有好处，但对于新生血管性AMD患者来说，仍然需要更多的治疗方法。许多AMD患者不符合PDT治疗条件，PDT治疗效果有限，成本高，有很大的改进空间。越来越多的人一致认为，联合治疗将是必要的，以提供真正的保护，防止严重的视力丧失。目前还没有经过证实的治疗地理萎缩的方法。如果年龄相关性眼病研究（AREDS）和AMD并发症预防试验（CAPT）的结果显示膳食补充剂和/或预防性激光治疗有益，则保护作用可能是中等的，留下改进的空间。

Age-related macular degeneration is the leading cause of blindness in the United States and most developed countries. The need for evaluation of new treatment approaches for patients with AMD is great and likely to continue for many years. Despite the recently documented benefits of photodynamic therapy (PDT) with verteporfin, there is still great need for additional treatment approaches for patients with neovascular AMD. Many patients with AMD are not eligible for PDT and the limited magnitude of treatment benefit and the high cost of PDT leave much room for improvement. There is a growing consensus that combination therapies will be necessary to provide true protection from severe visual acuity loss. There are no proven treatments for geographic atrophy. If the results of the Age-Related Eye Disease Study (AREDS) and the Complications of AMD Prevention Trial (CAPT) show benefit to dietary supplements and/or prophylactic laser treatment, the protective effects are likely to be moderate, leaving room for improvement. The objectives of this proposal are: 1) To develop an infrastructure to accelerate the development and conduct of clinical trials of the treatment and prevention of age-related macular degeneration. The proposed network would assist collaborating investigators, working in partnership with NEI staff, in developing and implementing specific, detailed protocols for multicenter clinical trials. 2) To develop a detailed protocol for one or more clinical trials that would be the first to use the infrastructure. The Chair of the Network will be responsible for carefully reviewing the full range of potential areas for clinical trials and evaluating their importance and timeliness. He will confer with other leaders in the field, including the intramural staff of the NEI during the planning process.