Retinal vessel features as a marker of idiopathic intracranial hypertension treatment response: a secondary analysis of the idiopathic intracranial hypertension treatment trial

视网膜血管特征作为特发性颅内高压治疗反应的标志：特发性颅内高压治疗试验的二次分析

• 批准号: 10223317
• 负责人: Heather Elspeth Moss
• 金额: $ 19.41万
• 依托单位: STANFORD UNIVERSITY
• 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 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10223317
• 关键词: Acute; Animals; Area; Biological Markers; Blindness; Blood Vessels; Brain; Brain Diseases; Brain Neoplasms; Caliber; Case Series; Clinical; Clinical Trials; Confounding Factors (Epidemiology); Data; Data Set; Dimensions; Disease Marker; Drainage procedure; Event; Eye; Fractals; Functional disorder; Funding; Fundus; Goals; Human; Intervention; Intracranial Pressure; Intracranial Sinus Thrombosis; Logistic Regressions; Measurement; Measures; Medical; Methods; Modeling; Morbidity - disease rate; Operative Surgical Procedures; Optic Disk; Optic Nerve; Outcome; Papilledema; Patients; Physicians; Physiologic Intraocular Pressure; Plant Roots; Prediction of Response to Therapy; Pseudotumor Cerebri; Randomized Controlled Trials; Reporting; Research; Retina; Risk; Spinal Tap; Structure of central vein of the retina; Swelling; Techniques; Technology; Therapeutic; Time; Uncertainty; United States National Institutes of Health; Vision; Visit; Work; arteriole; base; candidate marker; clinical predictors; clinically relevant; eye blood vessel; hypertension treatment; imaging study; improved; insight; novel; outcome prediction; personalized medicine; pressure; primary outcome; response; response biomarker; retina blood vessel structure; secondary analysis; treatment response; treatment trial; venous sinus; venule; visual information

PROJECT SUMMARY There is a critical need for developing markers and predictors of both high intracranial pressure (ICP) and response to high ICP treatment, that will guide clinicians to appropriately personalize treatment for idiopathic intracranial hypertension (IIH) by targeting aggressive interventions to patients who are not responding to conservative treatments or are at risk of vision loss. This application seeks to develop measurements of retinal vascular changes in the posterior eye as novel clinically-relevant biomarkers to meet this need. These are promising biomarker candidates based on preliminary data. Furthermore, they are specific, objective, quantitative and can be derived from non-invasive technologies. The long-term goal of this research is to understand the time course and variability of retinal vascular changes associated with ICP changes. Though some retinal vascular changes in association with ICP have been described, others have not been systematically studied. Furthermore, how retinal vascular changes relate to other eye changes associated with ICP is poorly understood. Our central hypothesis is that retinal vascular changes in response to ICP treatment precede other ophthalmic changes and that these predict treatment response over the longer term. The objective of this proposal is to perform a secondary analysis of fundus photos collected as part of the NIH funded Idiopathic Intracranial Hypertension Treatment Trial (IIHTT, clinicaltrials.gov identifier NCT01003639) to define retinal vascular changes occurring during IIH treatment in the context of other markers of disease. The first aim is to define the spectrum of retinal vascular changes that occur during medical treatment of IIH by comparing retinal vascular features extracted from fundus photographs at baseline and study conclusion. The second aim is to establish early retinal vascular change as a marker of response to medical treatment in IIH by studying how changes between initial study visits (0-1 month) predict outcomes at 6 months.

项目总结 迫切需要开发高颅内压(ICP)和反应的标志物和预测因子 高颅内压治疗，这将指导临床医生适当个体化治疗特发性颅内 通过对保守治疗无效的患者进行积极干预来控制高血压(IIH) 或者有失明的危险。这项应用寻求开发测量视网膜后部血管变化的方法 眼作为新的临床相关生物标志物，以满足这一需求。这些都是很有前途的生物标志物候选者，基于 初步数据。此外，它们是特异的、客观的、定量的，可以由非侵入性衍生而来 技术。这项研究的长期目标是了解视网膜血管的时间进程和变异性 与国际比较方案变化相关的变化。虽然已经描述了一些与颅内压相关的视网膜血管变化， 其他的还没有得到系统的研究。此外，视网膜血管变化与其他眼睛变化之间的关系 与国际比较方案相关的知识知之甚少。我们的中心假设是视网膜血管的变化是对颅内压的反应 治疗先于其他眼部变化，这些变化预测了较长期的治疗反应。这个 这项提案的目的是对NIH资助的眼底照片进行二次分析 特发性颅内高压治疗试验(IIHTT，Clinicaltrials.gov标识符NCT01003639)以定义视网膜 在IIH治疗期间发生的血管变化与其他疾病标志物相关。第一个目标是定义 通过比较视网膜血管特征了解内科治疗IIH期间视网膜血管的变化 从基线眼底照片中提取，并得出研究结论。第二个目标是建立早期视网膜 血管变化作为IIH患者治疗反应的标志--通过研究初始研究访问之间的变化 (0-1个月)预测6个月后的结果。