治疗并延长与按需给药方案玻璃体内注射康柏西普治疗新生血管性年龄相关性黄斑变性：COCOA研究结果，一项前瞻性、开放标签、多中心、随机IV期临床试验
Treat-And-Extend Versus Pro Re Nata Regimen of Intravitreal Conbercept Injection for Neovascular Age-Related Macular Degeneration: Results from COCOA, a Prospective, Open-Label, Multicenter, Randomized Phase IV Clinical Trial.
作者信息
Sun Yaoyao, Zhang Wenfang, Hu Bojie, Sun Bin, Zhang Tonghe, Yu Suqin, Yuan Gongqiang, Dai Rongping, Fan Ke, Wang Lifei, Cheng Pei, An Gang, An Liangbao, Wang Fang, Chen Weiqi, Zhang Jie, Zhou Xiyuan, Wang Feng, Ye Jian, Huang Xionggao, Peng Xiaoyan, Li Jun, Wu Miaoqin, Wan Guangming, Zhong Jingxiang, Ha Shaoping, Ke Xiao, Liang Jianhong, Qi Huijun, Yin Hong, Qian Tong, Qu Jinfeng, Shi Xuan, Hou Jing, Miao Heng, Yao Yuou, Jin Enzhong, Deng Xun, Zhang Jian, Shi Xiaoqing, Liu Jun, Ma Jie, Liu Jia, Tao Ye, Liu Bin, Li Xiaoxin, Zhao Mingwei
机构信息
Department of Ophthalmology, Peking University People's Hospital, Beijing, China.
Beijing Key Laboratory of Ocular Disease and Optometry Science, Beijing, China.
出版信息
Semin Ophthalmol. 2025 Jul;40(5):393-399. doi: 10.1080/08820538.2025.2467853. Epub 2025 Mar 13.
PURPOSE
To evaluate and contrast the effectiveness and safety of two conbercept treatment protocols-a three-dose treat-and-extend (3+T&E) regimen and a three-dose pro re nata (3+PRN) regimen-in Chinese patients diagnosed with neovascular age-related macular degeneration (nAMD).
METHODS
Eligible patients, who had not undergone anti-VEGF intraocular injections within 3 months prior to enrollment, were randomly assigned to either the 3+T&E or 3+PRN regimen. The 3+T&E group received at least three monthly injections, with subsequent visit intervals extended based on disease activity assessment. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) from baseline to week 48, using a predefined noninferiority threshold.
RESULTS
Among 501 participants (249 in 3+T&E, 252 in 3+PRN), approximately half had prior anti-VEGF treatment. At 48 weeks, both regimens showed significant BCVA improvements (+9.9 for 3+PRN, +8.6 for 3+T&E; = .208), with comparable rates of ≥15-letter gains (32.12% for 3+PRN, 30.77% for 3+T&E; = .827). The 3+PRN group received fewer injections (mean 6.4 vs. 6.9 in 3+T&E; = .028) but had shorter intervals between injections (6.93 weeks vs. 7.46 weeks in 3+T&E; = .010). Drug-related adverse events occurred in 5% of patients, with ocular events evenly distributed and minimal cardiovascular events reported.
CONCLUSION
Both 3+T&E and 3+PRN conbercept regimens effectively improved visual and anatomical outcomes in Chinese nAMD patients. The 3+T&E regimen was noninferior to 3+PRN in improving BCVA from baseline to week 48. The 3+T&E regimen enabled longer injection intervals while 3+PRN regimen with less injections is more cost-effective while maintaining a comparable safety profile. Treatment plan tailored to an individual patient's situation appears necessary.
目的
评估并对比两种康柏西普治疗方案——三剂量治疗并延长（3+T&E）方案和三剂量按需治疗（3+PRN）方案——对诊断为新生血管性年龄相关性黄斑变性（nAMD）的中国患者的有效性和安全性。
方法
符合条件的患者，即在入组前3个月内未接受过抗VEGF眼内注射的患者，被随机分配至3+T&E或3+PRN方案组。3+T&E组接受至少三个月一次的注射，随后根据疾病活动评估延长随访间隔。主要终点是使用预定义的非劣效性阈值，从基线至第48周最佳矫正视力（BCVA）的平均变化。
结果
在501名参与者中（3+T&E组249名，3+PRN组252名），约一半患者曾接受过抗VEGF治疗。在48周时，两种方案均显示BCVA有显著改善（3+PRN组提高9.9，3+T&E组提高8.6；P = 0.208），≥15字母增益的比例相当（3+PRN组为32.12%，3+T&E组为30.77%；P = 0.827）。3+PRN组接受的注射次数较少（平均6.4次，3+T&E组为6.9次；P = 0.028），但注射间隔较短（3+PRN组为6.93周，3+T&E组为7.46周；P = 0.010）。5%的患者发生与药物相关的不良事件，眼部事件分布均匀，报告的心血管事件极少。
结论
3+T&E和3+PRN两种康柏西普方案均有效改善了中国nAMD患者的视力和解剖学结果。从基线至第48周，3+T&E方案在改善BCVA方面不劣于3+PRN方案。3+T&E方案能够延长注射间隔，而3+PRN方案注射次数较少，在保持相当安全性的同时更具成本效益。根据个体患者情况制定治疗方案似乎很有必要。
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