Mental Status and Feasibility of an Intravitreal Ranibizumab Treat-and-Extend Regimen in Patients with Neovascular Age-Related Macular Degeneration
Mental Status and Feasibility of an Intravitreal Ranibizumab Treat-and-Extend Regimen in Patients with Neovascular Age-Related Macular Degeneration
复制标题
新生血管性年龄相关性黄斑变性患者的精神状态和玻璃体内雷珠单抗治疗和延长方案的可行性
DOI：
10.1007/s12325-022-02052-1
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发表时间：
2022
影响因子：
3.8
通讯作者：
Ogura Yuichiro
中科院分区：
文献类型：
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作者：
Kato Aki;Yasukawa Tsutomu;Sugita Iichiro;Yoshida Munenori;Nozaki Miho;Hirano Yoshio;Kondo Junko;Abe Tomohiro;Sugita Kimiko;Okita Takahide;Morita Hiroshi;Takase Noriaki;Ogura Yuichiro
抗血管内皮细胞生长因子(VEGF)治疗是治疗新生血管性老年性黄斑变性(NvAMD)的首选治疗方法，但患者往往存在生理、经济和精神负担。方法在这项前瞻性的多中心研究中，75例新生AMD患者接受雷尼比珠单抗玻璃体内注射治疗。在每月注射两次后，光学相干断层扫描(OCT)显示干性黄斑的眼睛的注射间隔逐步延长至6、8、12和16周，如果渗出持续或复发，则缩短一步。分别于注射前和注射当天进行最佳矫正视力(BCVA)测量和OCT检查。在基线时，所有患者都完成了关于精神负担的医院焦虑和抑郁量表(HADS)调查。结果51例(68%)患者完成为期1年的TAE方案，24只眼(32%)因抢救治疗、临床就诊困难或经济负担而终止TAE方案。在TAE方案治疗1年的51只眼中，平均BCVA从基线的64.3个字母改善到52周的71.6个字母。治疗1年后HADS焦虑和抑郁均分显著下降(p<； )。女性往往有较高的焦虑评分，可能与害怕注射和复发有关，而一些男性的抑郁评分较高，可能与经济负担、难以完成临床访问以及随后TAE方案的中断有关，尤其是在治疗效率较低的眼睛。结论玻璃体内注射雷尼比单抗的TAE方案保留了nvAMD患者的视力，并减少了与疾病复发相关的精神负担。试验注册：这项临床研究于2014年12月22日在临床试验NCT02321839上进行了回顾性注册。
IntroductionAnti-vascular endothelial growth factor (VEGF) therapy is the first-choice treatment for neovascular age-related macular degeneration (nvAMD); however, patients often are burdened physically, financially, and mentally. We investigated the relationship between mental status and feasibility of an intravitreal ranibizumab treat-and-extend (TAE) regimen for nvAMD.MethodsIn this prospective, multicenter study, 75 patients with nvAMD received ranibizumab intravitreally in a TAE regimen. After two monthly injections, the injection intervals were extended step-by-step to 6, 8, 12, and 16 weeks in eyes with dry maculas on optical coherence tomography (OCT) and, if exudation persisted or relapsed, shortened by one step. The best corrected visual acuity (BCVA) measurement and OCT were performed at baseline and on the same days of the scheduled injections. At baseline, all patients completed a survey, the Hospital Anxiety and Depression Scale (HADS), regarding mental burden. At week 52, patients on the TAE regimen for 1 year completed the HADS and a questionnaire designated to assess treatment-associated mental status.ResultsFifty-one patients (68%) completed the 1-year TAE regimen; 24 eyes (32%) discontinued the TAE regimen because of the rescue treatment, difficulty in completing clinical visits, or financial burden. In 51 eyes on the TAE regimen for 1 year, the mean BCVAs improved from 64.3 letters at baseline to 71.6 letters at week 52. The mean anxiety and depression scores on HADS decreased significantly (p< 0.01) after the 1-year treatment. Women tended to have higher anxiety scores, possibly associated with fear of injection and recurrence, while some men had higher depression scores potentially associated with financial burden, difficulty in completing clinical visits, and subsequent interruption of the TAE regimen especially in eyes with low treatment efficacy.ConclusionsA TAE regimen of intravitreal ranibizumab injections preserves vision in eyes with nvAMD and reduces mental burden associated with disease relapse.Trial registration:This clinical study was registered retrospectively on December 22, 2014 with the ClinicalTrials.gov identifier NCT02321839.