LI/NEI Repository Protocol

LI/NEI 存储库协议

• 批准号: 8737679
• 负责人: Robert Nussenblatt
• 金额: $ 2.13万
• 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/8737679
• 关键词: Adverse event; Aftercare; Anterior uveitis; Blood Vessels; Cells; Choroidal Neovascularization; Chronic; 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; Methotrexate; Microarray Analysis; Molecular Profiling; Natural History; Nature; Outcome; Panuveitis; Participant; Patients; Peripheral; Pharmaceutical Preparations; Posterior Uveitis; Procedures; Proteins; Protocols documentation; Redness; Research; Retinal; Risk; Safety; Sampling; Sarcoidosis; Scleritis; 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; intravitreal injection; macular edema; mortality; outcome forecast; peripheral blood; prospective; receptor; repository; research clinical testing; research study; screening; 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. Protocol 11-EI-0107: Evaluate the safety, tolerability and potential efficacy of intravitreal injections of methotrexate as a possible treatment for chronic macular edema secondary to panuveitis, posterior or intermediate uveitis. Most analyses will be primarily descriptive, including tabulations and graphical displays of outcomes over the course of the study.

除非获得额外使用的IRB批准，否则数据和样本分析将仅限于原始协议批准的数据。计划的分析（以前已根据其他协议批准）包括以下协议： 协议04-EI-0065：成功控制主动巩膜炎，定义为在开始英夫利昔单抗治疗后的14周内巩膜炎症的2步减少。免疫抑制药物，视觉模拟量表疼痛和发红数据，视力，实验室异常和不良事件将用于该方案。 协议96-EI-0096：安全参数的制表和审查，以及被认为受益于静脉内或皮下Daclizumab治疗的参与者的数量。视觉雾化，视力，不良事件和实验室数据的炎症评分将用于该协议。 协议06-EI-0239：建立用于预测眼和全身性结节病预后的免疫学和/或遗传标记。在眼和全身性结节病的管理中建立免疫学和/或遗传标记的临床重要性。 方案02-EI-0099：使用cDNA微阵列分析，在确定的临床阶段确定了独特的基因表达谱以及疾病相关的基因。将从与白介素（IL）蛋白及其受体以及肿瘤坏死因子（TNF）相关的选定集开始检查约5,000-12,000个基因。在活性或重复的炎症性疾病期间，在治疗后的静止期中再次采集样品。 协议04-EI-0115：研究达克珠单抗和西罗莫司组合疗法的可能疗效，以诱导出现非感染性中间和后葡萄膜炎的参与者的外周免疫耐受性。次要目标是研究研究疗法对疾病活动的影响，涉及前腔室细胞和雾霾，玻璃体雾度，黄斑水肿，视网膜渗漏和ETDR最佳校正视力。 协议05-EI-0178：直接评估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量风险有关。在确定此类患者是否需要免疫抑制治疗时产生关键信息，以及是否应避免某些免疫抑制剂。通过这种疗法评估短期并发症的频率以及治疗的眼部益处。 协议05-EI-0208：通过减少前腔室炎症的减少来衡量，评估达克珠单抗与JIA有关的活性葡萄膜炎的功效。次要结果将通过分析视力，玻璃体雾性，囊状黄斑水肿的观察，视网膜血管渗漏和视网膜增厚数据以及免疫抑制药物的分级评分。 协议00-EI-0204：这是一种评估和治疗方案，旨在跟踪患有各种眼部炎症性疾病的参与者。分析包括对标准治疗的审查。 协议98-EI-0085：这是一项筛查研究，旨在确定葡萄膜炎和眼部炎症性疾病的NEI研究的资格。最初的临床测试结果可以与入学参与者研究数据合并。 协议04-EI-0260：这是一种自然病史和标准治疗方案，旨在识别葡萄膜炎患者外周血中免疫激活的一系列标记物（例如Gitr，Socs3和IL15），这些标记与眼睛的免疫活性相关。 协议06-EI-0046：评估皮下依菲龙治疗治疗葡萄膜炎的安全性和潜在功效。分析包括与基线相比，OCT，视力和荧光素血管造影的变化。在整个研究过程中，使用全身毒性，不良事件和感染的性质，严重性和频率评估安全性。 方案06-EI-0111：评估联合免疫调节疗法的功效，或与参与者抗血管生成疗法结合使用，抑制与AMD相关的脉络膜新生血管形成的进展。观察到的结果将被列为列表，并审查研究程序，以确定临床结果是否暗示了趋势。 协议09-EI-0191：评估干扰素伽马1B的眼部滴注的安全性和可能功效，作为继发于葡萄膜炎的CME的有效治疗方法。分析将主要是描述性的，包括结果和结果的图形显示。 协议09-EI-0116：评估juncli骨亚象征的安全性，耐受性和潜在疗效，作为主动前葡萄膜炎的治疗方法。观察到的结果将被列为列表，并审查研究程序，以确定临床结果是否暗示了趋势。 协议10-EI-0186：评估微胞浆蛋白作为葡萄膜黄斑水肿的治疗方法的安全性和功效。观察到的结果将被列为列表，并审查研究程序，以确定临床结果是否暗示了趋势。 协议11-EI-0167：评估眼部伽马1B的眼部滴注的安全性和功效，作为继发葡萄膜炎的CME的潜在治疗方法。大多数分析将主要是描述性的，包括在整个研究过程中表现出结果和结果的图形显示。 协议11-EI-0107：评估玻璃体内注射甲氨蝶呤的安全性，耐受性和潜在疗效，作为继发于腹膜炎的慢性黄斑水肿，后验或中间葡萄膜炎的一种治疗方法。大多数分析将主要是描述性的，包括在整个研究过程中表现出结果和结果的图形显示。