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: 8213502
• 负责人: JUAN E GRUNWALD
• 金额: $ 15.34万
• 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/8213502
• 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 治疗试验比较试验 (CATT) 是一项多中心、随机临床试验，研究 Lucentis 和 Avastin 治疗新生血管性 AMD 的效果。本眼底照片阅读中心 (FPRC) 申请中提议的活动的主要目标是为 CATT 提供支持。这种支持包括 A) 评估随访眼底照片，以评估两种治疗后脉络膜新生血管的变化和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。该延续拨款提案有两个具体目标： 目标 1，在所有参与者中完成原始 CATT 拨款申请的两年后续行动。由于CATT试验的患者入组被推迟，完成两年随访所需的时间必须延长到原计划中提出的时间之外。目标 2，进行一项观察性研究，进行额外 3 年的随访，以调查研究药物的长期效果。在整个拟议研究中，FPRC 将为 CATT 提交的彩色照片和血管造影图像材料提供可靠、及时、可重复和系统的分级。这些活动将与 CATT 研究第一年提供的活动类似。 FPRC 还将继续为读者、摄影师、临床协调员和眼科医生认证和培训实施研究特定材料和方法。中非复兴人民阵线的活动还将支持研究目标，作为招募、研究组会议、演示和出版物的形象资源。相关性（参见说明）：年龄相关性黄斑变性 (AMD) 是美国和大多数西方国家失明的主要原因。这些对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未来如何治疗新生血管性（“湿性”）AMD 患者。