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 Coordinating Center will be responsible laying the foundation for implementing Web-based data capture that will facilitate accommodating efficiently a large number of clinical centers; summarizing and evaluating the existing information on candidate treatments, including basic science reports, clinical efficacy, and safety profiles; working with the Network Chair and other leaders in clinical research in AMD to develop detailed protocols for the proposed trial(s); developing prototypes of data collection forms that may be the basis of the forms required for prevention or treatment trials; organizing planning meetings; and preparing the Network Manual of Operations.
