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一种常用的抗炎治疗对改善视网膜脱离患者手术结果的潜在益处。“视网膜是一层很薄的膜，覆盖在眼睛的内部。它对光敏感（就像相机中的胶卷），是视觉所必需的。如果一个洞或裂缝在视网膜上发展，它可以成为脱离。视网膜脱离是最常见的眼部急症。对于五分之一的患者来说，脱离的视网膜可以在其表面上形成疤痕组织，这是一种称为“增殖性玻璃体视网膜病变”（PVR）的并发症。这种PVR疤痕组织会拉住视网膜，阻止通过标准手术修复孔或撕裂。疤痕组织会增加视网膜再次脱落的风险，需要更多的手术来解决问题。多次手术去除疤痕组织往往会导致视力不佳，无法满足患者的期望。阻止和治疗PVR瘢痕组织形成的努力迄今为止被证明是不成功的。我们的1期研究旨在证明一种已知抗炎药物的新型制剂的安全性和有效性，以及通过直接应用于患有视网膜脱离的患者眼睛内表面的治疗方法，处于PVR的高风险中。伦敦大学学院和Moorfields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。我们将只治疗那些被诊断为反复视网膜脱离并伴有瘢痕组织的患者，他们将在标准的眼科手术之外接受药物治疗。患者将在手术后接受6个月的监测，以观察药物的效果。这是一项重要的研究，因为目前还没有治疗方法可以阻止或治疗视网膜脱离中的PVR瘢痕组织。我们的目标是提供一种新的药物，最终将改善视力前景，减少眼科手术的数量，提高视网膜脱离患者的生活质量。我们与英国国家玻璃体视网膜协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了全英国PVR复杂性视网膜脱离患者的未满足需求，大多数人将支持在玻璃体切除术治疗视网膜脱离期间在眼组织表面内局部递送一种新药，以最终阻止疤痕组织复发。来自Moorfields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，医疗和外科医生会议上分享我们的发现，我们的研究合作伙伴，并通过主要的公共患者慈善组织。