Subgroup analysis of the MARINA study of ranibizumab in neovascular age-related macular degeneration
Subgroup analysis of the MARINA study of ranibizumab in neovascular age-related macular degeneration
复制标题
DOI：
10.1016/j.ophtha.2006.10.045
复制
发表时间：
2007-02-01
期刊：
影响因子：
13.7
通讯作者：
Acharya, Nisha R.
中科院分区：
文献类型：
--
作者：
Boyer, David S.;Antoszyk, Andrew N.;Acharya, Nisha R.
目的：在雷珠单抗治疗年龄相关性黄斑变性（AMD）继发的最小经典或隐匿性无经典脉络膜新生血管（CNV）的MARINA研究中，对临床相关患者亚组进行了检查。目的是确定雷珠单抗在各亚组中的有效性，比较雷珠单抗与假注射在亚组中的有效性，并评估选定的基线特征与视力（VA）结果之间的关系。设计：回顾性亚组分析来自MARINA研究的24个月数据。716例患者被随机分配到0.3 mg雷珠单抗组（n = 238）、0.5 mg雷珠单抗组（n = 240）或假治疗组（n = 238）。使用单变量分析，基于患者的性别、年龄、基线VA评分、基线CNV病变大小、CNV病变类型和新生血管性AMD的持续时间，在亚组之间比较疗效结局。对VA评分从基线到24个月的变化进行多变量分析，以进一步评估基线特征和VA结局之间的相关性。主要结局指标：从基线丢失< 15个字母的患者比例，从基线增加>= 15个字母的患者比例，以及从基线的平均VA评分变化。对于3个VA终点中的每一个，雷珠单抗治疗患者的所有亚组的平均表现均优于假治疗患者。年龄的增加、基线时CNV病变大小的增大以及基线VA评分的升高均与假手术组中字母丢失的增加或雷珠单抗组中字母增加的减少相关。然而，雷珠单抗与假治疗的净效益是更大的患者得分高于那些得分较低的基线VA。结论：这24个月的数据从MARINA研究亚组分析表明，雷珠单抗治疗与平均增加从基线VA在所有亚组评估，雷珠单抗治疗是上级假治疗在所有亚组。VA结局的最重要预测因素为基线VA评分、CNV病变大小和年龄（按重要性降序排列）。
Objective: An examination of clinically relevant subgroups of patients in the MARINA study of ranibizumab in treatment of minimally classic or occult with no classic choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) was done. Objectives were to determine the effectiveness of ranibizumab across subgroups, compare the effectiveness of ranibizumab with that of sham injection within subgroups, and evaluate the relationship between selected baseline characteristics and visual acuity (VA) outcomes.Design: Retrospective subgroup analyses of 24-month data from the MARINA study.Participants and Controls: Seven hundred sixteen patients were randomly assigned to 0.3 mg ranibizumab (n = 238), 0.5 mg ranibizumab (n = 240), or sham treatment (n = 238).Methods: Efficacy outcomes were compared across subgroups based on patients' gender, age, baseline VA score, baseline CNV lesion size, CNV lesion type, and duration of neovascular AMD using univariate analyses. Multivariate analyses were performed on the change from baseline to 24 months in VA score-to assess further the correlation between baseline characteristics and VA outcome.Main Outcome Measures: Proportion of patients losing < 15 letters from baseline, proportion gaining >= 15 letters from baseline, and mean VA score change from baseline.Results: For each of the 3 VA end points, all subgroups of ranibizumab-treated patients did better on average than the sham-treated patients. Increasing age, larger CNV lesion size at baseline, and a higher baseline VA score were all associated with greater loss of letters in the sham group or less gain of letters in the ranibizumab groups. However, the net benefit of ranibizumab versus sham treatment was greater in patients who scored higher than in those who scored lower in baseline VA.Conclusions: This subgroup analysis of 24-month data from the MARINA study indicates that ranibizumab treatment was associated with an average increase from baseline VA in all subgroups evaluated, and that ranibizumab treatment was superior to sham treatment across all subgroups. The most important predictors of VA outcomes were, in decreasing order of importance, baseline VA score, CNV lesion size, and age.