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玻璃体内注射贝伐单抗治疗年龄相关性黄斑变性继发脉络膜新生血管:一项开放标签非对照临床研究的6个月结果

Intravitreal bevacizumab therapy for choroidal neovascularization secondary to age-related macular degeneration: 6-month results of an open-label uncontrolled clinical study.

作者信息

Giansanti F, Virgili G, Bini A, Rapizzi E, Giacomelli G, Donati M C, Verdina T, Menchini U

机构信息

Department of Oto-Neuro-Ophthalmological Surgical Sciences, Eye Clinic, University of Florence, Viale Morgagni 85, 50134 Florence, Italy.

出版信息

Eur J Ophthalmol. 2007 Mar-Apr;17(2):230-7. doi: 10.1177/112067210701700213.

DOI:10.1177/112067210701700213
PMID:17415697
Abstract

PURPOSE

To investigate the 6-month safety and clinical outcomes of intravitreal injections of bevacizumab administered to treat choroidal neovascularization secondary to age-related macular degeneration.

METHODS

Twenty-seven patients underwent 1.25 mg intravitreal injections of bevacizumab at baseline. A similar intravitreal injection was administered to all eyes at 1 and 2 month follow-up visits. At baseline and at each follow-up visit (1, 2, 3, and 6 months), patients underwent best-corrected visual acuity (BCVA) measurement, fluorescein angiography, indocyanine green angiography, and optical coherence tomography. Laboratory testing, visual field analyses, and endothelial cell counts were performed at baseline and third and sixth months.

RESULTS

At 3 months, the mean BCVA remained substantially stable at 20/100. Mean central retinal thickness (CRT) decreased from 373 to 279 microm (p<0.01). Mean lesion greatest linear dimension (GLD) decreased from 4087 to 3782 microns (p<0.01). At 6 months, mean BCVA slightly decreased from 20/100(-1) to 20/125(-3) (not significant, p=0.40). Mean CRT was still inferior to baseline (305 microm, p<0.01). Mean lesion GLD was 4186 microm, not different from baseline values (p=0.59), but superior to 3-month mean GLD (p<0.01). Significant visual field defects or endothelial cell losses were not detected at 3 and 6 months. Laboratory testing did not reveal any clinically significant deviations compared to baseline values.

CONCLUSIONS

Intravitreal therapy using bevacizumab over 6 months showed stabilization of visual acuity and choroidal neovascularization activity; the safety data were convincing.

摘要

目的

研究玻璃体内注射贝伐单抗治疗年龄相关性黄斑变性继发脉络膜新生血管的6个月安全性及临床疗效。

方法

27例患者在基线时接受1.25mg玻璃体内注射贝伐单抗。在1个月和2个月的随访时,所有患眼均接受类似的玻璃体内注射。在基线及每次随访(1、2、3和6个月)时,患者接受最佳矫正视力(BCVA)测量、荧光素血管造影、吲哚菁绿血管造影及光学相干断层扫描。在基线、第3个月和第6个月进行实验室检查、视野分析及内皮细胞计数。

结果

3个月时,平均BCVA基本稳定在20/100。平均中心视网膜厚度(CRT)从373微米降至279微米(p<0.01)。平均病变最大线性尺寸(GLD)从4087微米降至3782微米(p<0.01)。6个月时,平均BCVA从20/100(-1)略有下降至20/125(-3)(无显著性差异,p=0.40)。平均CRT仍低于基线(305微米,p<0.01)。平均病变GLD为4186微米,与基线值无差异(p=0.59),但优于3个月时的平均GLD(p<0.01)。在3个月和6个月时未检测到明显的视野缺损或内皮细胞丢失。与基线值相比,实验室检查未发现任何具有临床意义的偏差。

结论

6个月使用贝伐单抗的玻璃体内治疗显示视力及脉络膜新生血管活动稳定;安全性数据令人信服。

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