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首页> 外文期刊>Controlled clinical trials >Surveillance of the eye and vision in a clinical trial of MART1-transformed dendritic cells for metastatic melanoma.
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Surveillance of the eye and vision in a clinical trial of MART1-transformed dendritic cells for metastatic melanoma.

机译：MART1转化的树突状细胞用于转移性黑色素瘤的临床试验中的眼睛和视力监测。

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Purpose: To report the protocol for surveillance of the eye and vision in a clinical trial of MART1-transduced dendritic cells for metastatic melanoma. Methods: In a phase I/II clinical trial of dendritic cell-based genetic immunotherapy for metastatic cutaneous melanoma, ophthalmic evaluation is performed prior to immunization (Baseline Evaluation), 56+/-7 days after first vaccination (mid-study evaluation), when dendritic cell injections are complete 112+/-7 days after first vaccination (end-study evaluation) and 168+/-7 days after first vaccination (post-study evaluation). Results: The protocol for baseline, mid-study and end-study evaluations of the eye and vision includes ophthalmic history, comprehensive ophthalmic examination, psychophysical and electrophysiological visual function assessment, fundus photography and fluorescein angiography. Post-study evaluation consists of the 25-item visual functioning questionnaire augmented to elicit autoimmune manifestation with complete ophthalmic evaluation if vision-related symptoms or abnormalities are noted during or after the vaccination. Conclusion: Limited adverse effects on the eye and vision have been reported in melanoma immunotherapy trials, although this novel mode of therapy has the potential to induce melanoma paraneoplastic syndromes known to severely impair vision. Therefore, surveillance of the eye and vision should be considered in melanoma immunotherapy trials.
机译：目的：报告在MART1转导的树突状细胞治疗转移性黑色素瘤的临床试验中监测眼睛和视觉的方案。方法：在针对转移性皮肤黑色素瘤的基于树突细胞的基因免疫疗法的I / II期临床试验中，在免疫接种之前（基线评估），第一次接种疫苗后56 +/- 7天进行眼科评估（中期研究评估），当首次接种后112 +/- 7天（最终研究评估）和首次接种后168 +/- 7天（研究后期评估）完成树突状细胞注射。结果：对眼睛和视觉进行基线，中期研究和最终研究评估的方案包括眼科病史，全面眼科检查，心理和电生理视觉功能评估，眼底照相和荧光素血管造影。研究后评估由25个项目的视觉功能问卷组成，如果在疫苗接种期间或之后发现与视觉相关的症状或异常，则可通过全面的眼科评估来增强自身免疫表现。结论：在黑素瘤免疫疗法试验中，对眼睛和视力的不良影响有限，尽管这种新的治疗方式有可能诱发已知严重损害视力的黑素瘤副肿瘤综合症。因此，在黑色素瘤免疫治疗试验中应考虑对眼睛和视力的监视。

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