Eye Exams Associated with Anetumab Ravtansine Administration

NCI方案：10107“Anetumab Ravtansine和MK-3475(Pembrolizumab)与单独MK-3475(Pembrolizumab)治疗间硫蛋白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” 由Schirmer试验评估的泪液产生和眼压(IOP)的变化预计不会作为anetumab ravtansine治疗的直接结果。然而，由于局部使用类固醇滴眼液治疗，一些患者的眼压可能会升高。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。 眼压的变化应该由眼科医生来处理。治疗方法应由研究人员酌情决定或根据机构标准进行选择；治疗措施可包括根据当地护理标准修改局部类固醇滴眼液的类型或姿势、开始局部降眼压药物和任何其他治疗选择。眼科监测应持续到眼压恢复正常为止。 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，但是发生包括角膜上皮缺陷在内的眼表疾病的风险因素。因此，在这项研究中将评估泪液产生，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的高危患者。Schirmer试验中的异常值应由眼科医生进行评估和处理，以便为角膜上皮提供足够的保护。对于Schirmer‘s试验(干眼)的紧急变化，治疗的补救方法应由研究人员自行决定或根据机构标准进行选择。这些措施可以包括局部润滑剂，如眼药水和药膏，准时遮盖，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。

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.