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Efficacy and safety of efdamrofusp alfa versus aflibercept in participants with neovascular age-related macular degeneration: a randomized, double-masked, active-controlled, non-inferiority, phase 2 trial

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机构： [1]Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [2]National Clinical Research Center for Ophthalmic Diseases, Shanghai,China. [3]Shanghai Key Laboratory of Fundus Diseases,Shanghai, China. [4]Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai, China. [5]Department of Ophthalmology, General Hospital of Central Theater Command [6]Department of Ophthalmology, The Second Hospital of Anhui Medical University [7]Department of Ophthalmology, Jinan Second People's Hospital [8]The Eye Hospital Affiliated to Shandong Traditional Chinese Medicine University [9]Department of Ophthalmology, The People's Hospital of Guangxi Zhuang Autonomous Region [10]Department of Ophthalmology, Army Medical Center of PLA [11]Innovent Biologics, Inc., Suzhou, China [12]Department of Ophthalmology, Jiangnan University Medical Center [13]Department of Ophthalmology, Tongji Hospital of Tongji University [14]Department of Ophthalmology, Jiangsu Province Hospital [15]The Affiliated Eye Hospital of Nanjing Medical University [16]Department of Ophthalmology, Zhejiang Provincial People's Hospital [17]Guangzhou Aier Eye Hospital [18]Department of Ophthalmology, The First Bethune Hospital of Jinlin University [19]Department of Ophthalmology, The First Affiliated Hospital of Zhejiang University School of Medicine [20]Department of Ophthalmology, Beijing Hospital [21]Department of Ophthalmology, The Second Affiliated Hospital of Xi’an Jiaotong University [22]Department of Ophthalmology, Peking University People's Hospital [23]Department of Ophthalmology,Xiangya Hospital Central South University [24]Department of Ophthalmology, Huai'an First People’s Hospital [25]Department of Ophthalmology, Renmin Hospital of Wuhan University [26]Department of Ophthalmology, The First Affiliated Hospital of Xi'an Jiaotong University [27]National Clinical Research Center for Ocular Diseases,Eye Hospital, Wenzhou Medical University [28]Department of Ophthalmology, The Affiliated Hospital of Guizhou Medical University [29]Department of Ophthalmology, The Affiliated Hospital of Xuzhou Medical University [30]Hebei Eye Hospital [31]Ningbo Eye Hospital [32]Department of Ophthalmology, Affiliated Hospital of Nantong University [33]Department of Ophthalmology, The First Affiliated Hospital of Chongqing Medical University [34]Henan Provincial Eye Hospital [35]Department of Ophthalmology, Lanzhou University Second Hospital [36]Department of Ophthalmology, The Affiliated Hosptial ofInner Mongolia Medical University [37]Department of Ophthalmology, Lishui Municipal Central hospital [38]Department of Ophthalmology, Beijing Tongren Hospital [39]Department of Ophthalmology, Xinjiang UIGER Municipal People's Hospital [40]Department of Ophthalmology, Peking University Shenzhen Hospital [41]Department of Ophthalmology, The First Affiliated Hospital of Soochow University

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关键词： Complement Neovascular Age-related Macular Degeneration Efdamrofusp alfa Macular Atrophy Fibrosis

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To evaluate efficacy and safety of efdamrofusp alfa compared with aflibercept in neovascular age-related macular degeneration (nAMD).Randomized, double-masked, multicenter, active-controlled, non-inferiority phase 2 study PARTICIPANTS: A total of 231 treatment-naïve and previously treated participants with active choroidal neovascularization secondary to nAMD were enrolled.Eligible participants were randomized (1:1:1) to 2 mg efdamrofusp alfa, 4 mg efdamrofusp alfa or 2 mg aflibercept groups. Participants in all groups received three initial monthly loading doses, followed by treatment every 8 weeks with assessment every 4 weeks up to week 52.The primary endpoint was the mean BCVA change from baseline to week 36. The pre-specified noninferiority margin was set as -5 letters (80% CI).Each treatment group included 77 participants. The mean BCVA changes from baseline to week 36 for 2 mg efdamrofusp alfa, 4 mg efdamrofusp alfa and aflibercept groups were +10.6, +11.4, +12.0 letters, respectively; Least Squares (LS) mean difference were -1.4 (80% CI: -3.5 to 0.7) between 2 mg efdamrofusp alfa and aflibercept, and -0.6 (80% CI: -2.7 to 1.6) between 4 mg efdamrofusp alfa and aflibercept. Mean central retinal thickness changes were consistent across groups. Adverse event rate was comparable among the groups.Efdamrofusp alfa demonstrated noninferiority to aflibercept in BCVA improvement, accompanied by a similar safety profile.Copyright © 2024. Published by Elsevier Inc.

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第一作者机构： [1]Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [2]National Clinical Research Center for Ophthalmic Diseases, Shanghai,China. [3]Shanghai Key Laboratory of Fundus Diseases,Shanghai, China. [4]Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai, China.

通讯作者：

通讯机构： [1]Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [2]National Clinical Research Center for Ophthalmic Diseases, Shanghai,China. [3]Shanghai Key Laboratory of Fundus Diseases,Shanghai, China. [4]Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai, China.

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Efficacy and safety of efdamrofusp alfa versus aflibercept in participants with neovascular age-related macular degeneration: a randomized, double-masked, active-controlled, non-inferiority, phase 2 trial

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