Steroids and Cross-linking for Ulcer Treatment (SCUT II)

类固醇和交联治疗溃疡 (SCUT II)

基本信息

批准号：
10666415
负责人：
THOMAS M LIETMAN
金额：
$ 74.59万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10666415
关键词：
Address Adjuvant Adjuvant Therapy Affect Age Agreement Anterior Anti-Inflammatory Agents Antibiotic Therapy Antibiotic susceptibility Antibiotics Asia Astigmatism Bacterial Infections Biological Blindness Case Series Case Study Cataract Cell secretion Cells Characteristics Cicatrix Clinical Clinical Trials Design Collaborations Collagen Confocal Microscopy Cornea Corneal Opacity Corneal Ulcer Country Developing Countries Drug resistance Eligibility Determination Enzymes Eye Eyeglasses Funding Future Genus Mycobacterium Hospitals Image Imaging Techniques Immune In Vitro India Infection Infectious Agent Inflammation Inflammatory Inflammatory Response International Investigation Keratitis Masks Measures Monocular Vision Morbidity - disease rate Moxifloxacin Operative Surgical Procedures Optics Organism Outcome Patients Penetrating Keratoplasty Perforation Persons Placebos Process Prognosis Pseudomonas aeruginosa Quality of life Randomized Randomized Controlled Clinical Trials Randomized, Controlled Trials Rehabilitation therapy Research Resistance Resolution Riboflavin Role Specific qualifier value Steroids Streptococcus pneumoniae Subgroup Technology Testing Therapeutic Tissues Topical Antibiotic Topical Corticosteroids Ulcer Visual Visual Acuity Visual impairment acute infection arm burden of illness collagenase corneal scar crosslink cytokine design disability healing high resolution imaging improved improved outcome innovation melting novel optimal treatments pathogen pathogenic bacteria prospective protein degradation randomized controlled design randomized trial randomized, clinical trials success symptomatic improvement treatment group trial comparing

项目摘要

PROJECT SUMMARY/ABSTRACT Investigating factors that mitigate the inflammatory response to infection may have the greatest impact on clinical outcomes in bacterial keratitis. Well-designed randomized controlled trials comparing different topical antibiotics have been unable to identify any significant difference of treatment success. Activated immune cells secret cytokines and collagenases which lead to destruction of corneal tissue. Simultaneous treatment of inflammation may reduce corneal astigmatism and opacity, thus improving visual acuity outcomes. The Steroids for Corneal Ulcer Trial (SCUT) was unable to identify a benefit or harm to the use of adjuvant steroids in the treatment of bacterial ulcers overall, however, hypothesis-generating subgroup analysis consistently suggested a benefit in severe, non-Nocardia ulcers treated with early steroids. Here, we propose the Steroids and Cross-linking for Ulcer Treatment II (SCUT II), an international, randomized, double-masked, clinical trial designed to evaluate the benefit of adjuvant corneal cross-linking (CXL) and early steroids in the treatment of bacterial ulcers. Patients presenting to one of the Aravind Eye Hospitals in India or to UCSF with smear-positive typical (i.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of three treatment groups: Group 1: Standard Therapy Group, topical 0.5% moxifloxacin plus topical placebo plus sham CXL Group 2: Early Steroid Group, topical 0.5% moxifloxacin plus topical 0.05% difluprednate plus sham CXL Group 3: CXL Group, topical 0.5% moxifloxacin plus topical 0.05% difluprednate plus CXL This approach is innovative for a number of reasons including its testing of novel treatments such as topical difluprednate 0.05% and corneal cross-linking. It is also aligned with the priorities of the NEI including the study of infectious processes, as well as studying new high-resolution imaging techniques such as confocal microscopy, anterior-segment optical coherence and Pentacam Scheimflug imaging to guide treatment of corneal ulceration and as potential surrogate trial endpoints in future trials. Proctor has a proven track record of studying the optimal treatment of corneal ulceration with large NEI-funded trials. Corneal opacity remains one of the leading causing of blindness worldwide and we anticipate that this research will guide clinicians on the best management of cornea infection to reduce the morbidity associated with this condition.

项目摘要/摘要调查减轻感染炎症反应的因素可能对细菌性角膜炎的临床结局。精心设计的随机对照试验比较不同的局部抗生素无法确定治疗成功的任何显着差异。活化的免疫细胞导致角膜组织破坏的秘密细胞因子和胶原酶。同时治疗炎症可以减少角膜散光和不透明度，从而改善视力结果。这角膜溃疡试验（SCUT）的类固醇无法识别辅助类固醇的益处或伤害然而，在总体上治疗细菌性溃疡时，假设生成的亚组分析始终如一建议在早期类固醇治疗的严重的非心脏病溃疡中受益。在这里，我们提出了溃疡治疗II（SCUT II）的类固醇和交联，国际，旨在评估佐剂角膜交联的好处的随机，双掩盖，临床试验（CXL）和早期类固醇治疗细菌性溃疡。出现在Aravind眼中的患者印度的医院或带有涂片阳性的UCSF（即非心脏病或霉菌）细菌角膜溃疡和中度至重度视力丧失，定义为Snellen视力为20/40或更差，将有资格包容。那些同意参加的人将被随机分为三个治疗组之一：第1组：标准疗法组，局部0.5％莫西法沙星加上局部安慰剂加上假cxl 第2组：早期类固醇组，局部0.5％Moxifloxatin加上局部0.05％difluprednate加上假CXL 第3组：CXL组，局部0.5％Moxifloxatin加上局部0.05％Difluprednate加上CXL 由于多种原因，这种方法具有创新性 Difluprednate 0.05％和角膜交联。它也与NEI的优先级一致，包括研究传染过程，以及研究新的高分辨率成像技术，例如共焦显微镜，前部段光学连贯性和五角星Scheimflug成像，以指导治疗在以后的试验中，角膜溃疡和潜在的替代试验终点。 Proctor有一个可靠的记录通过大型NEI资助试验研究角膜溃疡的最佳治疗。角膜不透明仍然是一个全世界失明引起的主要原因，我们预计这项研究将指导临床医生角膜感染的最佳管理，以减少与这种情况相关的发病率。