A Novel Device for Ultra-Rapid Non-Pharmacologic Ocular Anesthesia

一种用于超快速非药物眼部麻醉的新型装置

• 批准号: 9410112
• 负责人: Thomas W Chalberg
• 金额: $ 58.11万
• 依托单位: IRENIX MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-30 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9410112
• 关键词: Achievement; Address; Adverse effects; Analgesics; Anesthesia procedures; Anesthetics; Animals; Blurred vision; Body Weight decreased; Clinical; Clinical Trials; Custom; Data; Device Safety; Device or Instrument Development; Devices; Diffusion; Drug Delivery Systems; Enrollment; Eye; FDA approved; Feasibility Studies; Food and Drug Administration Device Approval; Formulation; Gel; Health Services Accessibility; Hour; Human; Injection of therapeutic agent; Interview; Lidocaine; Macular degeneration; Medical; Medicine; Nerve Endings; Neural Conduction; Oryctolagus cuniculus; Outcome; Pain; Pain management; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Physicians; Pilot Projects; Procedures; Production; Randomized; Records; Reporting; Retina; Retinal Diseases; Retinal Vein Occlusion; Safety; Site; Specialist; Study Subject; Subconjunctival Hemorrhage; System; Technology; Temperature; Testing; Time; Tissues; Toxic effect; United States; Vascular Endothelial Growth Factors; Vision; Visual Acuity; Work; arm; base; cold temperature; commercialization; corneal epithelium; design; diabetic; ergonomics; experience; human data; human subject; improved; intravitreal injection; macular edema; novel; ocular surface; oral pain; patient safety; pre-clinical; prototype; research clinical testing; safety testing; satisfaction; standard of care; success

PROJECT SUMMARY / ABSTRACT The objective of this Phase II proposal is to further develop a novel device for ocular anesthesia based on thermo-electric cooling. Intravitreal injection therapy (IVT) is one of the most commonly performed procedures in all of medicine, with approximately 7 million injections in the USA in 2016. Ocular anesthesia is required, both for patient safety and for tolerability of these vision-preserving injections. To date, all local ocular anesthetics are lidocaine based and function via diffusion of this medication through ocular tissues. Drug diffusion into deeper ocular layers and nerve endings takes between 5-10 minutes and is associated with corneal epithelial toxicity, resulting in post-injection pain and blurred vision. To address the limitations of currently available ocular anesthesia, we have created a device that uses precisely-regulated cold temperatures to deliver focal, ultra-rapid, non-pharmacologic anesthesia to the ocular surface immediately before IVT administration. Pre-clinical device safety testing did not show any evidence of toxicity in rabbits. In addition, our early feasibility study demonstrated proof-of-concept and confirmed safety in humans, with effective anesthesia and no toxicity in study subjects. In this proposal, we aim to further optimize temperature and time point settings of our novel focal anesthesia by thermo-electric cooling (FAnTEC) device in an expanded phase II feasibility study. Data obtained from this trial will be used to design the commercial-ready prototype with a simplified user interface, and this device will be tested in a pivotal phase III clinical trial to support FDA device approval. If successful, this project will lay the groundwork for device manufacturing and commercialization of the FAnTEC device, improving the IVT experience for millions of patients receiving IVT in the United States and around the world. !

项目总结/摘要 本II期提案的目的是进一步开发一种基于眼麻醉的新型器械， 热电制冷的研究玻璃体内注射治疗（IVT）是最常用的治疗方法之一， 在所有的医学程序，约700万注射在美国在2016年。眼部麻醉是 为了患者的安全性和这些视力保护注射的耐受性，都需要。到目前为止，所有当地眼 麻醉剂是基于利多卡因的并且通过该药物通过眼组织的扩散而起作用。药物 扩散到更深的眼层和神经末梢需要5-10分钟， 角膜上皮毒性，导致注射后疼痛和视力模糊。 为了解决目前可用的眼部麻醉的局限性，我们已经创建了一个设备， 精确调节的低温，为眼部提供局灶性、超快速、非药物麻醉 在IVT给药前立即浮出水面。临床前器械安全性试验未显示任何证据 对兔子的毒性此外，我们的早期可行性研究证明了概念验证，并证实了 对人体有效麻醉，对研究对象无毒性。 在这个提议中，我们的目标是进一步优化我们的新焦点的温度和时间点设置。 在一项扩大的II期可行性研究中，使用热电冷却（FAnTEC）装置进行麻醉。数据 将用于设计具有简化用户界面的商业原型， 该设备将在关键的III期临床试验中进行测试，以支持FDA的设备批准。如果成功， 该项目将为FAnTEC器件的制造和商业化奠定基础， 改善美国和世界各地数百万接受IVT的患者的IVT体验。 !