Photograph Reading Center for the Comparison of AMD Treatments Trial

AMD 治疗试验比较照片阅读中心

• 批准号: 8141945
• 负责人: JUAN E GRUNWALD
• 金额: $ 36.74万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8141945
• 关键词: Age related macular degeneration; Angiography; Applications Grants; Archives; Avastin; Blindness; Blood Vessels; Caliber; Certification; Characteristics; Choroidal Neovascularization; Clinic; Clinical; Clinical Investigator; Clinical Research; Color; Computer software; Country; Data; Data Correlations; Databases; Effectiveness; Enrollment; Evaluation; Extravasation; Exudative age-related macular degeneration; Film; Fluorescein; Fundus; Future; Goals; Group Meetings; Growth; Image; Injection of therapeutic agent; Instruction; Lesion; Long-Term Effects; Lucentis; Measures; Methods; Observational Study; Ophthalmologist; Optical Coherence Tomography; Optics; Participant; Pathology; Patients; Pharmaceutical Preparations; Principal Investigator; Procedures; Protocols documentation; Publications; Randomized Clinical Trials; Reader; Reading; Relative (related person); Reproducibility; Research Infrastructure; Research Personnel; Resources; Retinal; Safety; Secure; Site; System; Time; To specify; Tomogram; Training; Training Programs; Treatment Efficacy; United States; Visit; base; bevacizumab; digital; digital imaging; follow-up; neovascular; quality assurance; retina blood vessel structure; transmission process; treatment trial

DESCRIPTION (provided by applicant): The Comparison of AMD Treatments Trial (CATT) is a multi-center, randomized clinical trial investigating the treatment of neovascular AMD with Lucentis and Avastin. The primary objective of the activities proposed in this fundus Photograph Reading Center (FPRC) application is to provide support to the CATT. This support includes A) the evaluation of follow-up visit fundus photographs to assess the changes in the choroidal neovascularization and the changes in retinal vessel diameters following both treatments; and B) assessment of the correlation of these findings with the findings of the CATT OCT Reading Center. This continuation grant proposal has two Specific Aims: Aim 1, to complete in all participants the two-year follow up of the original CATT grant application. Because enrolment of patients in the CATT trial was delayed, the period needed to complete the two year follow up must be extended beyond the time period proposed in the original plan. Aim 2, to perform an observational study for an additional 3-year follow up to investigate the long term effects of the study medications. Throughout the proposed studies the FPRC will provide reliable, timely, reproducible, and systematic grading of submitted color photographs and angiographic image materials for CATT. These activities will be similar to those provided in the first years of the CATT study. The FPRC will also continue to implement study specific materials and methods for reader, photographer, clinic coordinator, and ophthalmologist certification and training. FPRC activities will also support study goals as an image resource for recruitment, Study Group meetings, presentations and publications. RELEVANCE (See instructions): Age-related macular degeneration (AMD) is the leading cause of blindness in the United States and most western countries. These studies of the relative effectiveness and safety of the two drugs under study will determine how patients with neovascular ("wet") AMD are treated in the future.

描述（由申请人提供）：AMD治疗试验（CATT）的比较是一项多中心的随机临床试验，研究了与Lucentis和lucentis和avastin对新血管AMD的处理。在此Fellus照片阅读中心（FPRC）应用中提出的活动的主要目标是为CATT提供支持。该支持包括a）评估后续访问眼底照片，以评估两种处理后的脉络膜新生血管形成变化以及视网膜血管直径的变化； b）评估这些发现与CATT OCT阅读中心的发现的相关性。该延续赠款提案有两个具体的目标：目标1，以在所有参与者中完成原始CATT赠款申请的两年随访。由于延迟了CATT试验中患者的入学率，因此完成两年随访所需的时间必须延长到原始计划中提出的时间段之外。 AIM 2，进行观察性研究进行额外的3年随访，以研究研究药物的长期影响。在整个拟议的研究中，FPRC将提供可靠，及时，可重现和系统的分级，用于CATT提交的彩色照片和血管造影图像材料。这些活动将与CATT研究的头几年相似。 FPRC还将继续为读者，摄影师，诊所协调员和眼科医生认证和培训实施特定的材料和方法。 FPRC活动还将支持学习目标，作为招聘，研究小组会议，演讲和出版物的图像资源。相关性（请参阅说明）：与年龄相关的黄斑变性（AMD）是美国和大多数西方国家失明的主要原因。这些研究中两种正在研究的药物的相对有效性和安全性的研究将决定新血管（“湿”）AMD的患者将来如何治疗。