LI/NEI Repository Protocol

数据和样品分析将仅限于根据原始协议批准的数据和样品，除非获得额外的特定用途IRB批准。先前根据其他协议批准的计划分析包括以下协议： 方案04-EI-0065：活动性巩膜炎的成功控制，定义为在开始英夫利昔单抗治疗后14周内巩膜炎症两步减少。免疫抑制药物、视觉模拟评分疼痛和红肿数据、视力、实验室异常和不良事件将被存储并针对该方案进行分析。 方案96-EI-0096：安全参数的列表和审查，以及被判断为从静脉或皮下注射Daclizumab治疗中受益的参与者的数量。对于该方案，将存储和分析视觉雾化、视力、不良事件和实验室数据的炎症评分。 方案06-EI-0239：建立免疫和/或遗传标记物，用于预测眼部和全身结节病的预后。确定免疫和/或遗传标记物在眼部和全身结节病治疗中的临床重要性。 协议02-EI-0099：使用基因芯片分析确定眼部炎症性疾病患者特定临床阶段的独特基因表达谱以及疾病相关基因。大约5,000-12,000个基因将从与白介素蛋白(IL)及其受体和肿瘤坏死因子(TNF)相关的一组精选基因开始进行检查。在炎症性疾病的活动期或复发期以及治疗后的静止期再次采集样本。 方案04-EI-0115：研究达利珠单抗和西罗莫司联合治疗在出现非感染性中间和后葡萄膜炎的参与者中诱导外周免疫耐受的可能疗效。第二个目标是研究治疗对疾病活动性的影响，包括前房细胞和haze、玻璃体haze、黄斑水肿、视网膜血管渗漏和ETDRS最佳矫正视力。 方案05-EI-0178：直接评估眼部炎症性疾病的免疫抑制治疗是否与额外的死亡率和癌症风险相关。生成关键信息，以决定是否需要对此类患者进行免疫抑制治疗，以及是否应该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：评估Daclizumab治疗与JIA相关的活动期葡萄膜炎的疗效，通过减少前房炎症来衡量。次要结果将通过分析视力、玻璃体混浊、观察黄斑囊样水肿、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分数来调查。 方案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回顾。 方案98-EI-0085：这是一项筛查研究，以确定是否符合NEI关于葡萄膜炎和眼炎性疾病的研究。最初的临床测试结果可以与登记的参与者研究数据结合在一起。 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组标志物(例如，GITR、SOCS3和IL15)，这些标志物与眼睛中的免疫活动状态相关。 方案06-EI-0046：评估皮下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。在整个研究过程中，使用全身毒性、不良事件和感染的性质、严重程度和频率来评估安全性。 方案06-EI-0111：评估联合免疫调节治疗或与参与者联合观察抗血管生成治疗在抑制AMD相关脉络膜新生血管进展方面的疗效。观察到的结果将被列成表格，研究程序将被审查，以确定临床结果是否表明一种趋势。 方案09-EI-0191：评估眼内滴注干扰素伽马-1b作为葡萄膜炎继发慢性葡萄膜炎的有效治疗方法的安全性和可能的疗效。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葡萄膜炎的安全性、耐受性和潜在疗效。观察到的结果将被列成表格，研究程序将被审查，以确定临床结果是否表明一种趋势。 方案10-EI-0186：评估微纤溶酶治疗葡萄膜黄斑水肿的安全性和有效性。观察到的结果将被列成表格，研究程序将被审查，以确定临床结果是否表明一种趋势。 方案11-EI-0167：评估干扰素伽马-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，包括研究过程中结果的表格和图形显示。 方案11-EI-0107：评估玻璃体内注射甲氨蝶呤治疗继发于全葡萄膜炎、后葡萄膜炎或中间葡萄膜炎的慢性黄斑水肿的安全性、耐受性和潜在疗效。大多数分析将主要是描述性的，包括研究过程中结果的表格和图形显示。

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.