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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

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机构: [1]Peking Univ, Peoples Hosp, Peoples Hosp, 11 Xizhimen South St, Beijing 100034, Peoples R China [2]Beijing Key Lab Ocular Dis & Optometry Sci, Beijing, Peoples R China [3]Peking Univ, Hlth Sci Ctr, Beijing, Peoples R China [4]Lanzhou Univ Second Hosp, Lanzhou, Peoples R China [5]Tianjin Med Univ, Eye Hosp, Tianjin, Peoples R China [6]Shanxi Eye Hosp, Taiyuan, Shanxi, Peoples R China [7]Second Peoples Hosp Jinan, Dept Ophthalmol, Jinan, Peoples R China [8]Shanghai Gen Hosp, Dept Ophthalmol, Shanghai, Peoples R China [9]Shandong First Med Univ & Shandong Acad Med Sci, Shandong Eye Hosp, Shandong Eye Inst, State Key Lab Cultivat Base,Shandong Prov Key Lab, Jinan, Peoples R China [10]Chinese Acad Med Sci, Peking Union Med Coll Hosp, Peking Union Med Coll, Dept Ophthalmol, Beijing, Peoples R China [11]Zhengzhou Univ, Henan Eye Hosp, Henan Eye Inst, Henan Branch ,Natl Clin Res Ctr Ocular Dis,Peoples, Zhengzhou, Henan, Peoples R China [12]Hebei Eye Hosp, Dept Ophthalmol, Xingtai, Hebei, Peoples R China [13]First Affiliated Hosp Xian Jiaotong Univ, Dept Cardiovasc Med, Xian, Shaanxi, Peoples R China [14]Jinzhou Cent Hosp, Jinzhou, Peoples R China [15]Shenyang He Eye Hosp, Dept Ophthalmol, Shenyang, Peoples R China [16]Shanghai Tenth Peoples Hosp, Shanghai, Peoples R China [17]Joint Shantou Int Eye Ctr Shantou Univ & Chinese, Shantou, Peoples R China [18]Shantou Int Eye Ctr, Shantou, Peoples R China [19]Nanjing Med Univ, Affiliated Wuxi 2 Peoples Hosp, Dept Ophthalmol, Wuxi, Jiangsu, Peoples R China [20]Chongqing Univ, Affiliated Hosp 2, Dept Ophthalmol, Chongqing, Peoples R China [21]Xi An Jiao Tong Univ, Affiliated Hosp 2, Dept Ophthalmol, Xian, Peoples R China [22]Chinese Peoples Liberat Army Army Special Med Zh C, Dept Ophthalmol, Chongqing, Peoples R China [23]Third Mil Med Univ, Army Specialty Med Ctr, Dept Ophthalmol, Chongqing, Peoples R China [24]Capital Med Univ, Beijing Tongren Hosp, Beijing Inst Ophthalmol, Beijing Tongren Eye Ctr,Beijing Ophthalmol & Visua, Haikou, Peoples R China [25]Shandong First Med Univ, Qingdao Eye Hosp, Eye Inst, Qingdao, Shandong, Peoples R China [26]Hangzhou Med Coll, Zhejiang Prov Peoples Hosp, Peoples Hosp, Dept Ophthalmol, Hangzhou, Zhejiang, Peoples R China [27]Zhengzhou Univ, Affiliated Hosp 1, Dept Ophthalmol, Zhengzhou, Peoples R China [28]Jinan Univ, Affiliated Hosp 1, Dept Ophthalmol, Jieyang, Peoples R China [29]Peoples Hosp Ningxia Hui Autonomous Reg, Ning Xia Eye Hosp, Dept Ophthalmol, Yinchuan, Peoples R China [30]Chengdu Kanghong Biotechnol Inc, Med Res Ctr, Chengdu, Sichuan, Peoples R China
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关键词: Conbercept Intravitreal neovascular age-related macular degeneration randomized clinical trial Treat-and-extend

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PurposeTo 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).MethodsEligible 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.ResultsAmong 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.ConclusionBoth 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.

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大类 | 4 区 医学
小类 | 4 区 眼科学
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大类 | 4 区 医学
小类 | 4 区 眼科学
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出版当年[2023]版:
Q2 OPHTHALMOLOGY
最新[2023]版:
Q2 OPHTHALMOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

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第一作者机构: [1]Peking Univ, Peoples Hosp, Peoples Hosp, 11 Xizhimen South St, Beijing 100034, Peoples R China [2]Beijing Key Lab Ocular Dis & Optometry Sci, Beijing, Peoples R China [3]Peking Univ, Hlth Sci Ctr, Beijing, Peoples R China
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通讯机构: [1]Peking Univ, Peoples Hosp, Peoples Hosp, 11 Xizhimen South St, Beijing 100034, Peoples R China [2]Beijing Key Lab Ocular Dis & Optometry Sci, Beijing, Peoples R China [3]Peking Univ, Hlth Sci Ctr, Beijing, Peoples R China
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