Chair Grant for the Comparison for AMD Treatment Trials

AMD 治疗试验比较主席 Grant

• 批准号: 7941569
• 负责人: DANIEL F MARTIN
• 金额: $ 5.2万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 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/7941569
• 关键词: Adopted; Age related macular degeneration; Amendment; American; Avastin; Blindness; Clinical Trials; Data; Development; Dose; Drug usage; Elderly; Enrollment; Epithelial; Exudative age-related macular degeneration; Eye; FDA approved; Follow-Up Studies; Frequencies; Funding; Grant; Head; Instruction; Label; Leadership; Lesion; Long-Term Effects; Lucentis; Medicare; Monoclonal Antibodies; National Eye Institute; Observational Study; Ophthalmologist; Optical Coherence Tomography; Outcome; Patients; Pattern; Pharmaceutical Preparations; Phase; Pigments; Policies; Publications; Randomized Clinical Trials; Regimen; Relative (related person); Request for Applications; Retreatment; Safety; Schedule; Secure; Therapeutic; Therapeutic Effect; Time; United States; Vascular Endothelial Growth Factors; Visual; Visual Acuity; arm; base; bevacizumab; comparative; comparative trial; cost; design; effective therapy; expectation; geographic atrophy; improved; neovascular; payment; prevent; ranibizumab; standard of care; treatment duration; treatment trial

DESCRIPTION (provided by applicant): In September, 2006, the National Eye Institute funded the Comparison of AMD Treatments Trials (CATT). This 4-arm, 1200 patient study was designed to determine the relative efficacy of Lucentis and Avastin and to evaluate their optimal dosing frequencies. Patient enrollment was planned to have begun in early 2007, however, regulatory hurdles including obtaining reimbursement for these agents by CMS extended the period of the trial beyond its current funding. In addition, it has become clear that the long term visual outcomes including safety and efficacy beyond two years are completely unknown. Given that Lucentis and Avastin are now the basis for virtually all AMD treatment worldwide and that these patients require continued dosing for many years beyond the previous periods of study, it is clear that the long term effects of these drugs must be understood. In this application, support for two initiatives is requested: Specific Aim #1: To complete the CATT: Lucentis-Avastin randomized clinical trial. The current period of funding ends August 2010. The last patient enrolled will complete their two year period of treatment in December 2011. Funding is requested to insure all patients are supported through completion of the first phase of the CATT study. Specific Aim #2: To conduct an observational Follow-up Study to investigate the course of visual acuity and the ocular and systemic safety of long-term treatment with Lucentis or Avastin. Patients who complete two years of treatment in the randomized clinical trial will be followed in an observational study for an additional three years. RELEVANCE (See instructions): The development of Lucentis and Avastin represents a major therapeutic improvement over previous therapies for AMD and has profoundly altered expectations regarding the extent of visual loss that can be prevented or reversed. No single study has compared the safety and efficacy of these two agents head to head or looked at comparative outcomes of these agents using monthly or "as needed" dosing regimens.

描述（由申请人提供）：2006年9月，国家眼科研究所资助了AMD治疗试验比较（CATT）。这项4组、1200例患者的研究旨在确定Lucentis和Avastin的相对疗效，并评估其最佳给药频率。患者招募计划于2007年初开始，然而，包括获得CMS对这些药物的报销在内的监管障碍延长了试验期，超出了目前的资金。此外，很明显，长期视力结局（包括2年后的安全性和有效性）完全未知。鉴于Lucentis和Avastin现在是全球几乎所有AMD治疗的基础，并且这些患者需要在之前的研究阶段之后持续多年给药，显然必须了解这些药物的长期影响。在本申请中，需要支持两项计划：具体目标#1：完成CATT：Lucentis-Avastin随机临床试验。本供资期于2010年8月结束。最后一名入组患者将于2011年12月完成其两年治疗期。要求提供资金，以确保所有患者在完成CATT研究的第一阶段时得到支持。具体目标#2：进行一项观察性随访研究，以调查Lucentis或Avastin长期治疗的视力过程以及眼部和全身安全性。在随机临床试验中完成两年治疗的患者将在观察性研究中再随访三年。相关性（参见说明）：Lucentis和Avastin的开发代表了对AMD先前疗法的重大治疗改进，并且深刻地改变了关于可以预防或逆转的视力丧失程度的期望。没有一项研究比较了这两种药物的安全性和有效性，也没有研究比较了这些药物使用每月或“按需”给药方案的结果。