Eval. of Minocycline as a Microglia Inhibitor in Tx of CRVO and BRVO

评估。

基本信息

批准号：
10020017
负责人：
Catherine Cukras
金额：
$ 9.91万
依托单位：
NATIONAL EYE INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
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/10020017
关键词：
Adverse event Affect Age-Years Anti-inflammatory Blindness Chronic Clinical Research Dose Effectiveness Exhibits Extravasation Eye Fluorescein Angiography Generations Human Inflammation Inflammatory Injections Injury Investigation Length Letters Liquid substance Masks Measures Mediation Microglia Minocycline Multicenter Studies Natural History Neurons Oral Outcome Participant Patient Recruitments Patients Pharmaceutical Preparations Placebos Process Property Randomized Retina Retinal Retinal Vein Occlusion Safety Severities Site Source Testing Tetracyclines Thick Time Toxic effect Treatment Factor Vascular Endothelial Growth Factors Visit Visual Acuity Withdrawal bevacizumab cellular targeting central retinal vein occlusion design histological studies improved inhibitor/antagonist macula macular edema placebo group primary outcome response secondary outcome vein occlusion

项目摘要

In these pilot, double-masked, randomized, multi-center studies, participants will receive monthly bevacizumab injections for the first three months, followed by PRN dosing. In addition, participants will take an oral dose of 100 mg of minocycline or placebo twice daily for 24 months. During each monthly visit, participants will have their visual acuity measured and will undergo OCT testing to measure retinal thickness. At the Month 3 visit and thereafter, participants will be evaluated for improvement and worsening and will be eligible for additional bevacizumab treatment and/or investigational product depending on which criteria they fulfill. Additionally, at Month 12, participants will also be evaluated for no improvement. The primary outcome is the difference in mean change in best-corrected visual acuity (BCVA), as measured in ETDRS letters, between the minocycline and placebo groups in the study eye at 12 months compared to baseline. Secondary outcomes include the difference between the minocycline and placebo groups in the number of intravitreal bevacizumab injections between 12 and 24 months and baseline, changes in mean macular sensitivity as measured by microperimetry at 3, 6, 12, 18 and 24 months compared to baseline, the mean change in BCVA at 24 months compared to baseline, changes in retinal thickness as measured by OCT at 6, 12, 18 and 24 months compared to baseline, number of participants improving 1 logOCT scale step at 12 and 24 months compared to baseline, as well as changes in fluid leakage in the macula as demonstrated by fluorescein angiography at 12 and 24 months compared to baseline. Safety outcomes include the number of participant withdrawals, the number and severity of systemic and ocular toxicities and the number of adverse events. BRVO and CRVO studies are designed similarly but are separate clinical studies as they each have their own natural history course. We therefore want to keep them separate as we compare responses to investigative drug. The studies have been expanded to include two sites in the UK. One site in the UK has started recruiting patients and has active study patients, the other site is activating shortly.

在这些飞行员，双掩盖，随机的多中心研究中，参与者将在头三个月内每月接受贝伐单抗注射量，然后进行PRN剂量。此外，参与者将每天两次服用100毫克米诺环素或安慰剂的口服剂量 24个月。在每月访问期间，参与者将测量其视力，并进行OCT测试以测量视网膜厚度。在第3个月的访问及之后，将对参与者进行改进和恶化的评估，并有资格获得其他贝伐单抗治疗和/或研究产品，具体取决于他们符合的标准。此外，在第12个月，还将对参与者进行评估。主要结果是与基线相比，研究眼中的米诺环素和安慰剂组之间在ETDRS字母中测得的最佳校正视力变化（BCVA）的平均变化差异。次要结果包括在12到24个月之间注射玻璃齐珠单抗的注射次数和基线之间的近距离菌群和安慰剂组之间的差异，平均黄斑敏感性的变化，如3、6、12、12、12、18和24个月在3、6、12、12、18和24个月时与基线的平均变化相比，在3、6、12、12、18和24个月的平均变化中，相比之下，相比之下，相比之下，bcva的平均变化是相比，相比之下。基线，与基线相比，参与者的数量在12和24个月时提高了1个徽标量表步骤，以及与基线相比，荧光素血管造影术在12和24个月的荧光素血管造影表明的黄斑流体泄漏变化。安全结果包括参与者戒断的数量，系统性和眼部毒性的数量和严重性以及不良事件的数量。 BRVO和CRVO研究的设计相似，但它们是独立的临床研究，因为它们每个人都有自己的自然历史课程。因此，我们希望将它们分开，因为我们将对调查药物的反应进行比较。研究已扩展到包括英国的两个地点。英国的一个站点已经开始招募患者并拥有活跃的研究患者，另一个部位正在激活。