Angiographic and optical coherence tomographic results of the MARINA study of ranibizumab in neovascular age-related macular degeneration
Angiographic and optical coherence tomographic results of the MARINA study of ranibizumab in neovascular age-related macular degeneration
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DOI：
10.1016/j.ophtha.2007.04.030
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发表时间：
2007-10-01
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：
Kaiser, Peter K.;Blodi, Barbara A.;Acharya, Nisha R.
目的：为了评估对血管内皮生长因子A（VEGF-A）抑制剂雷珠单抗的药效学反应，在一项治疗继发于年龄相关性黄斑变性（AMD）的最小经典或隐匿性无经典脉络膜新生血管的研究中，（命名为MARINA [抗VEGF抗体兰尼单抗治疗新生血管性AMD的最小经典/隐匿试验]）并将这些反应与假注射对照组进行比较。设计：回顾性24个月数据的（预先规定和特别）分析。参与者：716名患者随机接受0.3 mg雷珠单抗（n = 238）、0.5 mg雷珠单抗（n = 240）或假注射（n = 238）。在基线和第3、6、12和24个月进行立体眼底照相和荧光素血管造影（FA）。在基线、第7天、第1个月和第12个月，在一组研究点（46例患者）进行光学相干断层扫描（OCT）。主要结果测量：预先设定的次要终点是第12个月和第24个月时脉络膜新生血管总面积和脉络膜新生血管渗漏总面积较基线的平均变化。预先设定的探索性FA终点包括第12个月和第24个月时脉络膜新生血管病变和浆液性感觉性视网膜脱离（SSRD）面积较基线的平均变化。事后探索性FA结局指标包括无脉络膜新生血管渗漏的患者比例和视网膜下纤维组织/瘢痕面积随时间较基线的平均变化。OCT的预先设定的探索性终点是随着时间的推移，从基线的平均变化在中心点thicken.Results：在12和24个月，统计学显着的好处，ranibizumab超过假治疗观察到的脉络膜新生血管病变，总脉络膜新生血管，脉络膜新生血管渗漏，SSRD，和瘢痕/视网膜下纤维化的面积从基线的平均变化。在12个月（最终OCT），OCT中心凹中心点厚度的平均变化是一个显着减少在ranibizumab组与sham group.Conclusions相比：最低限度的经典或隐匿性与经典的新生血管性AMD与ranibizumab治疗的患者表现出改善，是一致的视力，FA和OCT的结果和上级，在假治疗的患者。
Objective: To assess pharmacodynamic responses to ranibizumab, an inhibitor of vascular endothelial growth factor A (VEGF-A), in a study of the treatment of minimally classic or occult with no classic choroidal neovascularization secondary to age-related macular degeneration (AMD) (designated MARINA [Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD]) and to compare these responses with those in a sham-injection control group.Design: Retrospective (prespecified and ad hoc) analyses of 24-month data.Participants: Seven hundred sixteen patients, randomized to 0.3-mg ranibizumab (n = 238), 0.5-mg ranibizumab (n = 240), or a sham injection (n = 238).Methods: Stereoscopic fundus photography and fluorescein angiography (FA) were done at baseline and months 3, 6, 12, and 24. Optical coherence tomography (OCT) was performed at a subset of investigative sites (46 patients) at baseline, day 7, and months 1 and 12.Main Outcome Measures: Prespecified secondary end points were mean change from baseline in total area of choroidal neovascularization and total area of leakage from choroidal neovascularization at months 12 and 24. Prespecified exploratory FA end points included mean change from baseline in the areas of the choroidal neovascularization lesion and serous sensory retinal detachment (SSRD) at months 12 and 24. Post hoc exploratory FA outcome measures included the proportion of patients with no leakage from choroidal neovascularization and mean change from baseline over time in the area of subretinal fibrous tissue/disciform scar. The prespecified exploratory end point for OCT was mean change from baseline over time in center point thickness.Results: At 12 and 24 months, statistically significant benefits of ranibizumab over sham treatment were observed for mean change from baseline in the areas of choroidal neovascularization lesion, total choroidal neovascularization, leakage from choroidal neovascularization, SSRD, and disciform scar/subretinal fibrosis. At 12 months (final OCT), the mean change in foveal center point thickness on OCT was a significant decrease in the ranibizumab group compared with the sham group.Conclusions: Patients with minimally classic or occult with no classic neovascular AMD treated with ranibizumab demonstrated improvement that was consistent for visual acuity, FA, and OCT outcomes and superior to that in sham-treated patients.