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 视网膜疾病是视力丧失的常见原因。对于许多这样的条件， 包括视网膜脱离和黄斑孔，唯一的治疗方法是手术。第一步 这样的手术是玻璃体切除术，是通过在 眼睛。每年，全球进行110万个玻璃体切除术，在美国执行30万 一个人，在大多数情况下 维持视网膜的压力并帮助康复。全球视网膜填塞市场最近是 2013年的价值为6450万美元，预计到2020年将达到7750万美元。 目前的最新状态使用膨胀气或硅油对 愈合期间的视网膜（棉花）。但是，这两种方法都是理想的，因此要解决这些 缺陷，此阶段2提案扩展了我们对使用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，即改良的聚（乙烯基醇）和聚乙烯 甘油）以一种形式形式产生独特的水凝胶系统，该系统的液态形式非常低但 然后凝胶通过眼睛中的交叉链接形成。该公式允许通过小型注射 手术端口后面是体内膨胀，导致360度视网膜润肤膜。这个独特 配方将消除对术后患者定位的需求，并将降低到小 在3-5周期间，很容易从眼睛清除的分子提供临时 退化之前的润肤力。第1阶段的数据支持所得设备将是 更耐心，几乎没有屈光问题和患者完全移动的能力 在2-3周内证明了降解，没有炎症反应，尽管这 降解时间也很可调。在此阶段2中，我们打算完善公式以改进 性能并在相关模型中验证它以证明功效。