新型抗VEGF融合蛋白Conbercept玻璃体腔注射治疗湿性年龄相关性黄斑变性的疗效评价

Evaluation of the effect of Conbercept intravitreal injection on wet age-related macular degeneration

目的评估新型抗血管内皮生长因子(VEGF)融合蛋白Conbercept玻璃体腔注射治疗湿性年龄相关性黄斑变性(AMD)的疗效和安全性。方法所有患者初诊时均行视力、眼压、眼科前后节常规检查,荧光素眼底血管造影(FFA)检查、相干光断层扫描(OCT)检查。湿性AMD的诊断依据FFA和OCT中典型性脉络膜新生血管(CNV)的显示。所有患眼均采用"3+PRN"方案进行眼内注射Conbercept治疗,眼内注射按规范流程标准进行操作。评估指标包括:视力、中心视网膜厚度(CRT)、荧光素渗漏率和CNV面积。根据再注射标准进行眼内重复注射,随访观察≥6个月。结果湿性AMD 30例(35只眼)治疗前基线平均视力(log MAR)为0.699±0.523,平均CRT为(354.56±120.92)μm,荧光素渗漏率为100.00%(35/35),平均CNV面积为(9.82±6.35)mm2。在观察终点时(初次注射后6个月)平均视力(log MAR)为0.305±0.357,平均CRT为(276.08±144.40)μm,荧光素渗漏率为5.71%(2/35),平均CNV面积为(5.63±3.47)mm2。与治疗前基线比较视力显著提高(P<0.01),CRT、荧光素渗漏率及CNV面积显著降低(P<0.01)。视力和CRT在初次治疗后1个月内得到快速的改善,之后视力保持缓慢提高,CRT保持缓慢降低。所有患眼无一例发生严重不良反应。结论新型抗VEGF融合蛋白Conbercept玻璃体腔注射治疗湿性AMD能够显著提高视力和恢复黄斑结构,起效快,并且持续改善,安全性高,无眼局部及全身不良反应,值得临床推广应用。

Objective To assess the safety and efficacy of Conbercept,a novel VEGF decoy receptor fusion pro-tein,in patients with neovascular age-related macular degeneration （AMD）. Methods All patients were examined for vis-ual acuity,intraocular pressure,and other routine ophthalmic examinations,as well as fundus fluorescein angiography （FFA）and optical coherence tomography （OCT）. The diagnosis of wet AMD is based on the classic choroidal neovascular-ization （CNV）in FFA and OCT. All affected eyes were injected with Conbercept intravitrously following a ＂ 3 ＋ PRN＂schedule. Outcome measures included visual acuity,central retinal thickness （CRT）,the rate of fluorescein leakage and the area of CNV. All patients were followed for 6 months. Results We enrolled 30 Wet AMD cases （35 eyes）. At base-line,mean visual acuity （logMAR）was 0. 699 ± 0. 523,average CRT was 354. 56 ± 120. 92 μm,rate of fluorescein leak-age was 100. 00% （35 / 35）,and the average area of CNV was 9. 82 ± 6. 35 mm2 . At the endpoint （6 months after the ini-tial injection）,the average visual acuity （logMAR）was 0. 305 ± 0. 357,average CRT was 276. 08 ± 144. 40 μm,rate of fluorescein leakage was 5. 71% （2 / 35）,and average CNV area was 5. 63 ± 3. 47 mm2. Compared with baseline the visual acuity improved significantly （P 〈 0. 01）,and CRT,CNV area and the rate of fluorescein leakage reduced significantly （ P 〈 0. 01）. Moreover,the visual acuity and CRT rapidly improved within the first month,and then continued to improve at slower rate. None of eyes had serious adverse reactions. Conclusion Intravitreal injection of Conbercept can significantly improve visual acuity and rehabilitate macular structure in wet AMD. Its effect onsets rapidly and followed by steady im-provement. Conbercept is safe. There were no ocular or systemic adverse reactions being found in this study.