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
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.
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
通讯作者:
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
推荐引用方式(GB/T 7714):
Sun Yaoyao,Zhang Wenfang,Hu Bojie,et al.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[J].SEMINARS IN OPHTHALMOLOGY.2025,doi:10.1080/08820538.2025.2467853.
APA:
Sun, Yaoyao,Zhang, Wenfang,Hu, Bojie,Sun, Bin,Zhang, Tonghe...&Zhao, Mingwei.(2025).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.SEMINARS IN OPHTHALMOLOGY,,
MLA:
Sun, Yaoyao,et al."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".SEMINARS IN OPHTHALMOLOGY .(2025)