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

本研究的目的是研究一种常用的抗炎治疗对改善视网膜脱离手术的潜在益处。视网膜是薄薄的一层，排列在眼睛内部。它对光很敏感（就像照相机里的胶片），是视觉所必需的。如果视网膜上出现一个洞或撕裂，它就会脱落。视网膜脱离是最常见的眼部急症。对于1 / 5的患者，脱离的视网膜表面会形成疤痕组织，这种并发症称为“增殖性玻璃体视网膜病变”（PVR）。这种PVR疤痕组织拉着视网膜，阻止了通过标准手术修复孔洞或撕裂。疤痕组织增加了视网膜再次脱离的风险，需要更多的手术来解决这个问题。多次手术切除疤痕组织通常会导致视力不佳，达不到患者的期望。迄今为止，阻止和治疗PVR瘢痕组织形成的努力被证明是不成功的。我们的i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，以及直接应用于视网膜脱离患者眼睛内表面的治疗方法，具有PVR的高风险。伦敦大学学院和摩尔菲尔德眼科医院的研究人员将对大约50名患者进行研究，以确定视网膜脱离患者最合适和最安全的药物剂量。我们将只治疗那些诊断为反复视网膜脱离并伴有瘢痕组织的患者，除了标准的眼部手术外，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，因为目前没有治疗方法可以停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的药物，最终改善视力，减少眼科手术的次数，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了全英国pvr并发症视网膜脱离患者的未满足需求，并且大多数人支持使用一种新的药物，在视网膜脱离的玻璃体切除手术中在眼组织表面局部递送，最终阻止疤痕组织复发。摩尔菲尔德的病人帮助我们开展了这项研究。他们将帮助我们解释结果，并与我们一起在医院患者意识日、医疗和外科医生会议、我们的研究合作伙伴以及主要的公共患者慈善组织分享我们的发现。

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.