Degradable hydrogel for retinal tamponade (phase 2)

用于视网膜填塞的可降解水凝胶（第 2 阶段）

• 批准号: 10219260
• 负责人: Gavin James Braithwaite
• 金额: $ 29.64万
• 依托单位: CAMBRIDGE POLYMER GROUP, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10219260
• 关键词: Address; Age; Alcohols; Animals; Behavior; Blindness; Crosslinker; Data; Deuterium Oxide; Device Removal; Devices; Eye; Formulation; Gases; Gel; Grant; Hydrogels; In Situ; Inferior; Inflammation; Inflammatory Response; Injections; Intention; Lead; Left; Liquid substance; Macular Hole; Methods; Modeling; Molecular Weight; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Patients; Performance; Phase; Polymers; Population; Positioning Attribute; Postoperative Period; Process; Prone Position; Property; Provider; Reaction; Refractive Indices; Retina; Retinal Detachment; Retinal Diseases; Retinal Perforations; Safety; Silicone Oils; System; Testing; Time; Validation; Viscosity; Vitrectomy; Work; analytical method; base; biomaterial compatibility; crosslink; design; efficacy study; efficacy testing; ethylene glycol; experience; experimental study; healing; improved; in vivo; men; novel; phase 1 study; preclinical study; pressure; programs; repaired; response; safety study; screening; sex; small molecule; success

Project Summary Retinal disorders are a common cause of debilitating vision loss. For many of these conditions, including retinal detachments and macular holes, the only treatment is surgery. The first step of all such surgeries is vitrectomy, the process of removing the vitreous gel through tiny ports in the front of the eye. Each year, 1.1 million vitrectomies are performed globally with 300,000 performed in the US alone, and in the majority of these cases a retinal tamponade is required to be left in the eye to maintain pressure on the retina and aid healing. The global retinal tamponade market was recently valued at USD $64.5 million in 2013 and is predicted to reach USD $77.5 million by 2020. The current state of the art uses either an expansile gas, or a silicone oil to exert pressure on the retina during healing (tamponade). However, neither method is ideal and therefore to address these deficiencies, this phase 2 proposal extends early work we performed on a novel hydrogel that uses two common synthetic biomedical polymers, namely a modified poly(vinyl alcohol) and poly(ethylene glycol) in a form that creates a unique hydrogel system that is very low viscosity in liquid form but then gels through crosslink formation in the eye. This formulation allows for injection through small surgical ports followed by in vivo expansion resulting in 360-degree retinal tamponade. This unique formulation will eliminate the need for post-operative patient positioning and will degrade to small molecules that are readily cleared from the eye over the period of 3-5 weeks providing a temporary tamponade force before degrading. Data from the Phase 1 supports that the resulting device will be more patient friendly with almost no refractive issues and the ability for the patient to be fully mobile and has proven degradation over 2-3 weeks with no inflammatory response, although this degradation time is also tunable. In this Phase 2 we intend to refine the formulation for improved performance and validate it within a relevant model to demonstrate efficacy.

项目摘要 视网膜疾病是使人衰弱的视力丧失的常见原因。对于许多这些条件， 包括视网膜脱离和黄斑裂孔，唯一的治疗方法是手术。第一步 这种手术是玻璃体切除术，通过玻璃体前部的微小端口移除玻璃体凝胶的过程。 the eye.每年，全球进行110万例玻璃体切除术，其中30万例在美国进行 在大多数情况下，需要将视网膜填塞物留在眼中， 维持视网膜压力并帮助愈合。全球视网膜填塞市场最近被 2013年价值6450万美元，预计到2020年将达到7750万美元。 现有技术使用可膨胀气体或硅油来对微胶囊施加压力。 视网膜愈合（填塞）。然而，这两种方法都不是理想的，因此为了解决这些问题， 缺陷，这个第二阶段的建议扩展了我们对一种新型水凝胶进行的早期工作， 两种常见的合成生物医学聚合物，即改性聚乙烯醇和聚乙烯 乙二醇）的形式，其产生独特的水凝胶体系，该水凝胶体系在液体形式下粘度非常低， 然后在眼中通过交联形成胶凝。该制剂允许通过小的 手术端口，随后是体内扩张，导致360度视网膜填塞。这种独特 该制剂将消除术后患者定位的需要，并将降解为小 在3-5周的时间内容易从眼睛中清除的分子， 在降解前填塞力。来自第1阶段的数据支持所得器械将 患者更友好，几乎没有屈光问题，患者能够完全移动的 并且已经证明在2-3周内降解而没有炎症反应，尽管这 降解时间也是可调的。在第二阶段，我们打算改进配方， 性能并在相关模型中验证以证明有效性。