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.

数据和样本分析将仅限于根据原始方案批准的数据和样本分析，除非获得额外的特定用途IRB批准。先前根据其他议定书核准的计划分析包括下列议定书：