Eye Exams Associated with Anetumab Ravtansine Administration

与 Anetumab Ravtansine 给药相关的眼科检查

• 批准号: 10038614
• 负责人: LEONARD FREEDMAND
• 金额: $ 3.2万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-31 至 2020-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10038614
• 关键词: Contact Lenses; Cornea; Defect; Disease; Eyedrops; Lubricants; Malignant Pleural Mesothelioma; Measures; Modification; Monitor; Normal Range; Ointments; Ophthalmic examination and evaluation; Ophthalmologist; Ophthalmology; Patients; Pharmaceutical Preparations; Phase; Physiologic Intraocular Pressure; Production; Protocols documentation; Randomized Clinical Trials; Research Personnel; Risk Factors; Running; Safety; Steroids; Syndrome; Testing; Therapeutic; Therapeutic Uses; corneal epithelium; eye dryness; high risk; mesothelin; ocular surface; standard of care

NCI Protocol: 10107 “Phase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and MK-3475 (Pembrolizumab) Compared to MK-3475 (Pembrolizumab) Alone for Mesothelin-Positive Malignant Pleural Mesothelioma” Changes in tear production as evaluated by the Schirmer test and in intraocular pressure (IOP) are not expected to occur as a direct consequence of anetumab ravtansine therapy. However, IOP may increase in some patients as a consequence of the therapy with topical steroid eye drops. Since these drugs may be required to manage the corneal epitheliopathy syndrome, IOP will be monitored during this study for patients receiving topical steroid eye drops. Changes in IOP should be managed by an ophthalmologist. The remedial therapy should be chosen at investigator’s discretion or according to the institutional standards; therapeutic measures can include modification of the type or posology of topical steroid eye drop, initiation of topical IOP lowering drugs and any other therapeutic options according to the local standard of care. Ophthalmological monitoring should be maintained until the IOP has returned to normal values. Reductions in tear production evaluated by the Schirmer test, while not being a part of the corneal epitheliopathy syndrome, are a risk factor for developing ocular surface disease including corneal epithelial defects. Therefore, the tear production will be evaluated in this study to determine if changes in this parameter may be helpful to identify patients at higher risk of developing corneal epitheliopathy syndrome. Abnormal values in the Schirmer test should be evaluated and managed by an ophthalmologist to provide adequate protection to the corneal epithelium. The remedial therapy for the treatment-emergent changes in the Schirmer’s test (dry eye) should be chosen at investigator’s discretion or according to the institutional standards. These measures may include topical lubricants such as eye drops and ointments, punctual occlusion, use of therapeutic contact lenses and any other treatment approaches according to the local standard of care.

NCI方案：10107“Anetumab Ravtansine联合MK-3475（Pembrolizumab）与MK-3475（Pembrolizumab）单药治疗间皮瘤阳性恶性胸膜间皮瘤的I期安全性导入和II期随机临床试验” 通过Schirmer试验评价的泪液生成变化和眼内压（IOP）变化预期不会作为anetumab ravtansine治疗的直接结果发生。 然而，局部类固醇滴眼液治疗可能导致某些患者的IOP升高。 由于可能需要这些药物来管理角膜上皮病综合征，因此在本研究期间将监测接受局部类固醇滴眼液的患者的IOP。 IOP的变化应由眼科医生管理。 应根据研究者的判断或根据机构标准选择补救治疗;治疗措施可包括修改局部类固醇滴眼液的类型或剂量，开始使用局部降IOP药物和根据当地标准治疗的任何其他治疗选择。 应保持眼科监测，直至IOP恢复正常值。 通过Schirmer试验评估的泪液产生减少，虽然不是角膜上皮病综合征的一部分，但却是发生眼表疾病（包括角膜上皮缺损）的风险因素。 因此，本研究将评价泪液生成，以确定该参数的变化是否有助于识别发生角膜上皮病综合征风险较高的患者。 Schirmer试验中的异常值应由眼科医生进行评估和管理，以提供对角膜上皮的充分保护。 治疗后出现的Schirmer试验（干眼）变化的补救治疗应由研究者自行决定或根据机构标准选择。 这些措施可能包括局部润滑剂，如滴眼液和软膏，点状闭塞，使用治疗性隐形眼镜和任何其他治疗方法，根据当地标准的护理。