A Phase 1 Dose Finding Study Of Intraocular Mitomycin-C Adjunct In Vitrectomy For Retinal Detachment And Proliferative Vitreoretinopathy (MORPH-1)

眼内丝裂霉素 C 辅助治疗视网膜脱离和增殖性玻璃体视网膜病变 (MORPH-1) 玻璃体切除术的 1 期剂量探索研究

• 批准号: MR/Y008626/1
• 负责人: Mahiul Muqit
• 金额: $ 155.94万
• 依托单位: University College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FY008626%2F1
• 关键词: Phase; Dose; Finding; Study; Intraocular

The aim of this study is to investigate the potential benefit of a commonly used anti-inflammatory treatment to improve the outcome of surgery in eyes with "retinal detachment." The retina is a thin layer, which lines the inside of the eye. It is sensitive to light (like the film in a camera) and is necessary for vision. If a hole or tears develop in a retina, it can become detached. Retinal detachment is the most common eye emergency. For 1 in 5 patients the detached retina can develop scar tissue on its surface, a complication termed "proliferative vitreoretinopathy" (PVR).This PVR scar tissue pulls on the retina preventing the holes or tears from being repaired by standard surgery. The scar tissue increases your risk of the retina detaching again, and requires more operations to resolve the problem. Multiple surgeries to remove the scar tissue often results in poor vision outcomes that do not meet patient's expectations. Efforts to stop and treat PVR scar tissue formation have so far proved unsuccessful. Our phase 1 study aims to demonstrate safety and efficacy of a novel formulation of a known anti-inflammatory drug and method of treatment by direct application to the internal surface of patient's eye with retinal detachment, at high risk of PVR. Researchers at University College London and Moorfields Eye Hospital will undertake a study of approximately 50 patients to define the most appropriate and safest dose of the drug in patients with retinal detachment. We will treat only patients who have a diagnosis of repeated retinal detachment complicated by scar tissue, and they will receive the drug, in addition to the standard eye operation. Patients will be monitored for 6-months after surgery to see the effects of the medication. This is an important study, as no treatment currently exists for stopping or treating PVR scar tissue in retinal detachment. We aim to deliver a new medication that will ultimately improve the vision outlook, reduce the number of eye operations and improve quality of life for our retinal detachment patients. We have conducted a contemporary survey with the national vitreoretinal society in the United Kingdom. Our vitreoretinal surgeon peers and colleagues have verified the unmet need for patients with PVR-complicated retinal detachment across the UK, and the majority would support the use of a new medication that is delivered locally within the eye tissue surfaces during vitrectomy surgery for retinal detachment to ultimately stop the scar tissue from coming back. Patients from Moorfields have helped us to develop this research. They will help us interpret the results and work with us to share our findings at hospital patient awareness days, medical and surgeon meetings, to our research partners, and through key public patient charity organisations.

本研究的目的是调查常用抗炎治疗的潜在益处，以改善患有“视网膜脱离”的眼睛的手术结果。视网膜是一层薄薄的层，位于眼睛内部。它对光敏感（就像相机中的胶片），并且是视觉所必需的。如果视网膜出现洞或撕裂，它可能会脱落。视网膜脱离是最常见的眼部急症。对于五分之一的视网膜脱离患者来说，其表面会形成疤痕组织，这种并发症被称为“增殖性玻璃体视网膜病变”(PVR)。这种 PVR 疤痕组织会拉扯视网膜，导致孔洞或撕裂无法通过标准手术修复。疤痕组织会增加视网膜再次脱落的风险，并且需要更多的手术来解决问题。多次手术去除疤痕组织通常会导致视力不佳，无法满足患者的期望。迄今为止，阻止和治疗 PVR 疤痕组织形成的努力尚未成功。我们的一期研究旨在证明一种已知抗炎药物的新配方的安全性和有效性，以及直接应用于患有视网膜脱离、PVR 高风险的患者眼睛内表面的治疗方法。伦敦大学学院和莫菲尔德眼科医院的研究人员将对大约 50 名患者进行一项研究，以确定视网膜脱离患者最合适和最安全的药物剂量。我们只会治疗被诊断为反复视网膜脱离并发疤痕组织的患者，除了标准眼部手术外，他们还将接受药物治疗。手术后将对患者进行为期 6 个月的监测，以观察药物的效果。这是一项重要的研究，因为目前尚无治疗方法可以阻止或治疗视网膜脱离中的 PVR 疤痕组织。我们的目标是提供一种新药物，最终改善视网膜脱离患者的视力、减少眼部手术次数并提高生活质量。我们与英国国家玻璃体视网膜学会进行了一项当代调查。我们的玻璃体视网膜外科医生同行和同事已经证实，英国各地 PVR 并发症性视网膜脱离患者的需求尚未得到满足，大多数人支持使用一种新药物，该药物在玻璃体切除手术期间局部输送到眼组织表面，以治疗视网膜脱离。最终阻止疤痕组织复发。来自莫菲尔德的患者帮助我们开展了这项研究。他们将帮助我们解释结果，并与我们合作，在医院患者意识日、内科和外科医生会议上向我们的研究合作伙伴以及通过主要的公共患者慈善组织分享我们的发现。