Yaoyao Sun, Wenfang Zhang, Bojie Hu, Bin Sun, Tonghe Zhang, Suqin Yu, Gongqiang Yuan, Rongping Dai, Ke Fan, Lifei Wang, Pei Cheng, Gang An, Liangbao An, Fang Wang, Weiqi Chen, Jie Zhang, Xiyuan Zhou, Feng Wang, Jian Ye, Xionggao Huang, Xiaoyan Peng, Jun Li, Miaoqin Wu, Guangming Wan, Jingxiang Zhong, Shaoping Ha, Xiao Ke, Jianhong Liang, Huijun Qi, Hong Yin, Tong Qian, Jinfeng Qu, Xuan Shi, Jing Hou, Heng Miao, Yuou Yao, Enzhong Jin, Xun Deng, Jian Zhang, Xiaoqing Shi, Jun Liu, Jie Ma, Jia Liu, Ye Tao, Bin Liu, Xiaoxin Li, Mingwei Zhao
{"title":"治疗和延长玻璃体内注射治疗新生血管性年龄相关性黄斑变性的对比：来自COCOA的结果，这是一项前瞻性、开放标签、多中心、随机IV期临床试验。","authors":"Yaoyao Sun, Wenfang Zhang, Bojie Hu, Bin Sun, Tonghe Zhang, Suqin Yu, Gongqiang Yuan, Rongping Dai, Ke Fan, Lifei Wang, Pei Cheng, Gang An, Liangbao An, Fang Wang, Weiqi Chen, Jie Zhang, Xiyuan Zhou, Feng Wang, Jian Ye, Xionggao Huang, Xiaoyan Peng, Jun Li, Miaoqin Wu, Guangming Wan, Jingxiang Zhong, Shaoping Ha, Xiao Ke, Jianhong Liang, Huijun Qi, Hong Yin, Tong Qian, Jinfeng Qu, Xuan Shi, Jing Hou, Heng Miao, Yuou Yao, Enzhong Jin, Xun Deng, Jian Zhang, Xiaoqing Shi, Jun Liu, Jie Ma, Jia Liu, Ye Tao, Bin Liu, Xiaoxin Li, Mingwei Zhao","doi":"10.1080/08820538.2025.2467853","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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; <i>p</i> = .208), with comparable rates of ≥15-letter gains (32.12% for 3+PRN, 30.77% for 3+T&E; <i>p</i> = .827). The 3+PRN group received fewer injections (mean 6.4 vs. 6.9 in 3+T&E; <i>p</i> = .028) but had shorter intervals between injections (6.93 weeks vs. 7.46 weeks in 3+T&E; <i>p</i> = .010). Drug-related adverse events occurred in 5% of patients, with ocular events evenly distributed and minimal cardiovascular events reported.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":21702,"journal":{"name":"Seminars in Ophthalmology","volume":" ","pages":"1-7"},"PeriodicalIF":1.9000,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Yaoyao Sun, Wenfang Zhang, Bojie Hu, Bin Sun, Tonghe Zhang, Suqin Yu, Gongqiang Yuan, Rongping Dai, Ke Fan, Lifei Wang, Pei Cheng, Gang An, Liangbao An, Fang Wang, Weiqi Chen, Jie Zhang, Xiyuan Zhou, Feng Wang, Jian Ye, Xionggao Huang, Xiaoyan Peng, Jun Li, Miaoqin Wu, Guangming Wan, Jingxiang Zhong, Shaoping Ha, Xiao Ke, Jianhong Liang, Huijun Qi, Hong Yin, Tong Qian, Jinfeng Qu, Xuan Shi, Jing Hou, Heng Miao, Yuou Yao, Enzhong Jin, Xun Deng, Jian Zhang, Xiaoqing Shi, Jun Liu, Jie Ma, Jia Liu, Ye Tao, Bin Liu, Xiaoxin Li, Mingwei Zhao\",\"doi\":\"10.1080/08820538.2025.2467853\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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; <i>p</i> = .208), with comparable rates of ≥15-letter gains (32.12% for 3+PRN, 30.77% for 3+T&E; <i>p</i> = .827). The 3+PRN group received fewer injections (mean 6.4 vs. 6.9 in 3+T&E; <i>p</i> = .028) but had shorter intervals between injections (6.93 weeks vs. 7.46 weeks in 3+T&E; <i>p</i> = .010). Drug-related adverse events occurred in 5% of patients, with ocular events evenly distributed and minimal cardiovascular events reported.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":21702,\"journal\":{\"name\":\"Seminars in Ophthalmology\",\"volume\":\" \",\"pages\":\"1-7\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-03-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Seminars in Ophthalmology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/08820538.2025.2467853\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Seminars in Ophthalmology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/08820538.2025.2467853","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
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.
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; p = .208), with comparable rates of ≥15-letter gains (32.12% for 3+PRN, 30.77% for 3+T&E; p = .827). The 3+PRN group received fewer injections (mean 6.4 vs. 6.9 in 3+T&E; p = .028) but had shorter intervals between injections (6.93 weeks vs. 7.46 weeks in 3+T&E; p = .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.
期刊介绍：
Seminars in Ophthalmology offers current, clinically oriented reviews on the diagnosis and treatment of ophthalmic disorders. Each issue focuses on a single topic, with a primary emphasis on appropriate surgical techniques.
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