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 协议：10107“Anetumab Ravtansine 和 MK-3475 (Pembrolizumab) 与单独使用 MK-3475 (Pembrolizumab) 治疗间皮素阳性恶性胸膜间皮瘤的 1 期安全磨合和 2 期随机临床试验” 通过 Schirmer 试验评估的泪液产生和眼内压 (IOP) 的变化预计不会作为阿奈单抗拉坦辛治疗的直接结果而发生。 然而，由于局部类固醇滴眼液治疗，某些患者的眼压可能会增加。 由于可能需要这些药物来控制角膜上皮病综合征，因此在本研究期间将对接受局部类固醇滴眼液的患者进行眼压监测。 眼压的变化应由眼科医生进行处理。 补救治疗应由研究者自行决定或根据机构标准选择；治疗措施可包括改变外用类固醇滴眼剂的类型或剂量、开始使用外用降眼压药物以及根据当地护理标准的任何其他治疗选择。 应维持眼科监测直至眼压恢复正常值。 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，但却是发生包括角膜上皮缺陷在内的眼表疾病的危险因素。 因此，本研究将评估泪液产生，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。 席默试验中的异常值应由眼科医生进行评估和管理，以便为角膜上皮提供充分的保护。 针对 Schirmer 试验（干眼）治疗中出现的变化的补救疗法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（例如滴眼剂和药膏）、泪点封闭、使用治疗性隐形眼镜以及根据当地护理标准的任何其他治疗方法。