LI/NEI Repository Protocol

LI/NEI 存储库协议

• 批准号: 8556882
• 负责人: Robert Nussenblatt
• 金额: $ 1.95万
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8556882
• 关键词: Adverse event; Aftercare; Anterior uveitis; Blood Vessels; Cells; Choroidal Neovascularization; Clinical; Combined Modality Therapy; Cystoid Macular Edema; Daclizumab; Data; Disease; Eligibility Determination; Enrollment; Evaluation; Extravasation; Eye; Fluorescein Angiography; Frequencies; Gene Expression; Genes; Genetic Markers; Human; Immune; Immune Tolerance; Immunologics; Immunosuppressive Agents; Infection; Inflammation; Inflammatory; Institutional Review Boards; Interferon gamma 1b; Interleukin-15; Interleukins; Intermediate Uveitis; Intravenous; Laboratories; Malignant Neoplasms; Measures; Microarray Analysis; Molecular Profiling; Natural History; Nature; Outcome; Participant; Patients; Peripheral; Pharmaceutical Preparations; Posterior Uveitis; Procedures; Proteins; Protocols documentation; Redness; Research; Retinal; Risk; Safety; Sampling; Sarcoidosis; Scleritis; Screening procedure; Secondary to; Severities; Sirolimus; Staging; Therapeutic immunosuppression; Toxic effect; Treatment Protocols; Tumor Necrosis Factors; Uveitis; Visual; Visual Acuity; Visual Analogue Pain Scale; active control; active method; anterior chamber; cDNA Arrays; design; efalizumab; effective therapy; immune activation; infliximab; macular edema; mortality; outcome forecast; peripheral blood; prospective; receptor; repository; research clinical testing; research study; secondary outcome; standard care; subcutaneous; trend

Data and sample analyses will be limited to those approved under the original protocols unless additional use-specific IRB approval is obtained. Planned analyses, previously approved under other protocols, include the following protocols: Protocol 04-EI-0065: Successful control of active scleritis defined as a 2-step decrease in scleral inflammation within 14 weeks of initiating infliximab treatment. Immunosuppressive medication, visual analogue scale pain and redness data, visual acuity, laboratory abnormalities and adverse events will be stored and analyzed for this protocol. Protocol 96-EI-0096: Tabulation and review of safety parameters and the number of participants judged to have benefit from either intravenous or subcutaneous daclizumab therapy. Inflammation scores for visual haze, visual acuity, adverse events and laboratory data will be stored and analyzed for this protocol. Protocol 06-EI-0239: Establish immunologic and/or genetic markers for predicting prognosis in ocular and systemic sarcoidosis. Establish the clinical importance of immunologic and/or genetic markers in the management of ocular and systemic sarcoidosis. Protocol 02-EI-0099: Identify unique gene expression profiles as well as disease relevant genes for patients with ocular inflammatory disease at defined clinical stages using cDNA microarray analysis. Some 5,000-12,000 genes will be examined starting with a selected set associated with interleukin (IL) proteins and their receptors, and with tumor necrosis factors (TNF). Samples were taken during periods of active or recurring inflammatory disease and again during periods of quiescence after treatment. Protocol 04-EI-0115: Investigate the possible efficacy of daclizumab and sirolimus combination therapy to induce peripheral immune tolerance in participants presenting with non-infectious intermediate and posterior uveitis. The secondary objective is to investigate the effect of study therapy on disease activity, regarding anterior chamber cells and haze, vitreous haze, macular edema, retinovascular leakage and ETDRS best-corrected visual acuity. Protocol 05-EI-0178: Evaluate directly whether immunosuppressive therapy for ocular inflammatory diseases is associated with an excess risk of mortality and of cancer. Generate critical information in deciding whether immunosuppressive therapy is warranted for such patients, and whether certain immunosuppressive agents should be avoided. Evaluate the frequency of short-term complications with such therapy, and the ocular benefits of therapy. Protocol 05-EI-0208: Evaluate the efficacy of daclizumab in the treatment of active uveitis, associated with JIA, as measured by a reduction of anterior chamber inflammation. Secondary outcomes will be investigated by analyzing the visual acuity, vitreous haze, observance of cystoid macular edema, retino-vascular leakage, and retinal thickening data, as well as the grading scores of immunosuppressive medications. Protocol 00-EI-0204: This is an evaluation and treatment protocol designed to follow participants with various ocular inflammatory diseases. Analysis includes review of standard treatments. Protocol 98-EI-0085: This is a screening study to determine eligibility for NEI research studies of uveitis and ocular inflammatory diseases. The initial clinical test results can be incorporated with enrolled participants study data. Protocol 04-EI-0260: This is a natural history and standard treatment protocol designed to identify a panel of markers (e.g., GITR, SOCS3 and IL15) of immune activation in the peripheral blood of uveitis patients that correlate with the state of the immune activity in the eye. Protocol 06-EI-0046: Evaluate the safety and potential efficacy of subcutaneous efalizumab treatments for the treatment of uveitis. Analysis includes the changes in OCT, visual acuity and fluorescein angiography compared to baseline. Safety is assessed using the nature, severity and frequency of systemic toxicities, adverse events and infections throughout the study. Protocol 06-EI-0111: Evaluate the efficacy of combination immunomodulatory therapy or observed in conjunction with the participants anti-angiogenic therapy on the inhibition of the progression of choroidal neovascularization associated with AMD. Observed outcomes will be tabulated and study procedures reviewed to determine if clinical outcomes suggest a trend. Protocol 09-EI-0191: Evaluate the safety and possible efficacy of ocular instillation(s) of interferon gamma-1b as an effective treatment for CME secondary to uveitis. Analyses will be primarily descriptive, including tabulations and graphical displays of outcomes. Protocol 09-EI-0116: Evaluate the safety, tolerability and potential efficacy of subconjunctival sirolimus as a treatment for active anterior uveitis. Observed outcomes will be tabulated and study procedures reviewed to determine if clinical outcomes suggest a trend. Protocol 10-EI-0186: Evaluate the safety and efficacy of microplasmin as a treatment for uveitic macular edema. Observed outcomes will be tabulated and study procedures reviewed to determine if clinical outcomes suggest a trend. Protocol 11-EI-0167: Evaluate the safety and efficacy of ocular instillations of interferon gamma-1b as a potential treatment for CME secondary to uveitis. Most analyses will be primarily descriptive, including tabulations and graphical displays of outcomes over the course of the study.

数据和样本分析将仅限于原始方案下批准的数据和样本分析，除非获得额外的特定用途IRB批准。先前根据其他方案批准的计划分析包括以下方案： 方案04-EI-0065：活动性巩膜炎的成功控制定义为开始英夫利西单抗治疗后14周内巩膜炎症的2步减少。本方案将储存并分析免疫抑制药物、视觉模拟量表疼痛和发红数据、视力、实验室检查异常和不良事件。 方案96-EI-0096：安全性参数和判定从静脉或皮下达克珠单抗治疗中获益的受试者数量的列表和审查。本方案将储存并分析视雾度、视力、不良事件和实验室数据的炎症评分。 方案06-EI-0239：建立免疫学和/或遗传学标记物以预测眼部和全身性结节病的预后。确定免疫学和/或遗传标记物在眼部和全身结节病治疗中的临床重要性。 方案02-EI-0099：使用cDNA微阵列分析确定特定临床阶段眼部炎症性疾病患者的独特基因表达谱以及疾病相关基因。大约5，000 - 12，000个基因将被检查，从与白细胞介素（IL）蛋白及其受体和肿瘤坏死因子（TNF）相关的选定集合开始。在活动性或复发性炎性疾病期间以及在治疗后静止期间再次取样。 方案04-EI-0115：研究达克珠单抗和西罗莫司联合治疗诱导非感染性中间和后葡萄膜炎受试者外周免疫耐受的可能疗效。次要目的是研究研究治疗对疾病活动性的影响，包括前房细胞和雾状混浊、玻璃体雾状混浊、黄斑水肿、视网膜血管渗漏和ETDRS最佳矫正视力。 方案05-EI-0178：直接评价眼部炎症性疾病的免疫抑制治疗是否与死亡率和癌症的过度风险相关。产生关键信息，以决定是否需要对此类患者进行免疫抑制治疗，以及是否应避免使用某些免疫抑制剂。评估这种治疗的短期并发症的频率，以及治疗的眼部益处。 方案05-EI-0208：评价daclizumab治疗与JIA相关的活动性葡萄膜炎的疗效，通过减少前房炎症来衡量。次要结局将通过分析视力、玻璃体混浊、黄斑囊样水肿观察、视网膜血管渗漏和视网膜增厚数据以及免疫抑制药物分级评分进行研究。 方案00-EI-0204：这是一项评估和治疗方案，旨在随访患有各种眼部炎症性疾病的受试者。分析包括标准治疗的审查。 方案98-EI-0085：这是一项筛选研究，旨在确定葡萄膜炎和眼部炎症性疾病NEI研究的合格性。初始临床试验结果可与入组受试者研究数据合并。 方案04-EI-0260：这是一种自然史和标准治疗方案，旨在识别一组标志物（例如，GITR、S 0 CS3和IL 15）的免疫激活，其与眼睛中的免疫活性状态相关。 方案06-EI-0046：评价皮下依法利珠单抗治疗葡萄膜炎的安全性和潜在疗效。分析包括OCT、视力和荧光素血管造影与基线相比的变化。在整个研究期间，使用全身毒性、不良事件和感染的性质、严重程度和频率评估安全性。 方案06-EI-0111：评价联合免疫调节治疗或观察到的联合抗血管生成治疗对抑制AMD相关脉络膜新生血管进展的疗效。将观察到的结局制成表格，并审查研究程序，以确定临床结局是否提示趋势。 方案09-EI-0191：评价干扰素γ-1b眼部滴注作为葡萄膜炎继发性CME有效治疗的安全性和可能疗效。分析将主要是描述性的，包括结果的表格和图形显示。 方案09-EI-0116：评价结膜下西罗莫司治疗活动性前色素层炎的安全性、耐受性和潜在疗效。将观察到的结局制成表格，并审查研究程序，以确定临床结局是否提示趋势。 方案10-EI-0186：评价微纤溶酶治疗葡萄膜炎性黄斑水肿的安全性和有效性。将观察到的结局制成表格，并审查研究程序，以确定临床结局是否提示趋势。 方案11-EI-0167：评价眼内滴注干扰素γ-1b作为葡萄膜炎继发CME潜在治疗方法的安全性和有效性。大多数分析将主要是描述性的，包括研究过程中结局的表格和图形显示。