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

基本信息

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
项目类别：
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

项目摘要

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. !

项目摘要 /摘要该阶段II提案的目的是进一步开发基于眼麻醉的新型设备在热电冷却下。玻璃体内注射疗法（IVT）是最常见的一种所有医学的程序，2016年在美国大约有700万次注射。眼睛麻醉是为了患者的安全和这些视力保护注射的耐受性，都需要。迄今为止，所有本地眼麻醉药是基于利多卡因的，并且通过这种药物通过眼组织扩散而功能。药品扩展到更深的眼层和神经末端需要5-10分钟，并且与角膜上皮毒性，导致注射后疼痛和视力模糊。为了解决当前可用的眼麻醉的局限性，我们创建了一种使用的设备精确调节的冷温度可为眼部提供局灶性，超高，非药物麻醉立即在IVT给药之前表面表面。临床前设备安全测试未显示任何证据兔子的毒性。此外，我们的早期可行性研究证明了概念证明并确认了人类，有效的麻醉，在研究对象中无毒性。在此提案中，我们旨在进一步优化新型焦点的温度和时间点设置在扩展的II期可行性研究中，热电冷却（FANTEC）设备进行麻醉。数据从该试验获得的将使用简化的用户界面设计商业就绪的原型，并且该设备将在一项关键的III期临床试验中进行测试，以支持FDA设备批准。如果成功，该项目将为Fantec设备的设备制造和商业化奠定基础，改善在美国和世界各地接受IVT的数百万患者的IVT经验。呢