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Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration: A Phase 3 Randomized Trial

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收录情况： ◇ ESCI

作者：
Jan Hamouz[1] * ; Agnieszka Nowosielska[2] ; Anna Święch-Zubilewicz[3] ; Santiago Abengoechea[4] ; Kristine Baumane[5] ; Attila Vajas[6] ; Małgorzata Siewierska[7] ; Milan Veselovsky[8] ; Miroslav Veith[9] ; Ágnes Kerényi[10] ; Shobhana Mange[11] ; Krishnapada Baidya[12] ; Guna Laganovska[13] ; Ignasi Jürgens[14] ; András Papp[15] ; Jignesh Gosai[16] ; Jana Štefanickova[17] ; Mei Han[18] ; Piotr Fryczkowski[19] ; Dominik Zalewski[20] ; Jing Wang[21] ; Wenbin Wei[22] ;
机构： [1]Department ofOphthalmology, University Hospital Kralovske Vinohrady,Prague, Czech Republic. [2]Ophthalmology and Eye Surgery Clinic, Warsaw Eye Hospital,Warsaw,Poland. [3]Department of Vitreoretinal Surgery, Medical University of Lublin, Independent Public Teaching Hospital No.1, Lublin, Poland. [4]Department of Ophthalmology, Barraquer Ophthalmology Center,Spain. [5]Department of Ophthalmology,Clinical Centre Bikemieki,Riga East University Hospital,LV- 1006 Riga, Latvia. [6]Department of Ophthalmology, University of Debrecen, Debrecen, Hungary. [7]Department of Ophthalmology,St. Rose Hospital,Kraków,Poland. [8]Department of Ophthalmology, University Hospital and Policlinic of Zilina, Slovakia. [9]Department ofOphthalmology, University Hospital Kralovske Vinohrady,Prague,Czech Republic. [10]Department of Ophthalmology, Bajcsy-Zsilinszky Hospital,Budapest 1106,Hungary. [11]Department of Ophthalmology, Shivam Retina Clinic and Eye Hospital, India. [12]Department of Ophthalmology, Regional Institute of Ophthalmology,Medical College,Kolkata, West Bengal, India. [13]Department of Ophthalmology, Pauls Stradins Clinical University Hospital,Riga,Latvia. [14]Retina and Vitreous Department, Institut Català de Retina,Barcelona, Spain. [15]Department of Ophthalmology, Semmelweis University, Budapest, Hungary. [16]Department of Ophthalmology, MJ Westem Regional Institute of Ophthalmology,India. [17]Department of Ophthalmology,Comenius University, University Hospital Ruzinov,Ruzinovskà 4810/6,821 01,Bratislava,Slovakia. [18]Department of Ophthalmology, Tianjin Eye Hospital, Tianjin, China. [19]Department of Ophthalmology, Retina Ophthalmological Outpatient Clinic and Hospital, Poland. [20]Department of Ophthalmology,Diagnostic and Microsurgery Center of the Eye LENS, 3a Budowlana Street,10-424 Olsztyn,Poland. [21]Clinical Research Centre,Qilu Pharmaceutical,Jinan,China. [22]Beijing Tongren Eye Center,Beijing Tongren Hospital,CapitalMedical University, Beijing, China.
出处：
DOI： 10.1016/j.oret.2024.10.001
ISSN：

关键词： The study was sponsored by Qilu Pharmaceutical Co Ltd The sponsor participated in the design of the study conducting the study and data management

摘要：
This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis®, in patients with neovascular age-related macular degeneration (nAMD).This was a multi-center, double-blinded, randomized controlled phase 3 trial.Treatment-naïve patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab.Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every four weeks for 48 weeks.The primary endpoint was change in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 compared to baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49.Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n=308) and the reference ranibizumab group (n=308). The mean improvement of BCVA was +6.3±9.13 ETDRS letters in the QL1205 group and +7.3±8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI) [-2.23, 0.13] and 95% CI [-2.46, 0.36] of the difference between the two treatment groups (P=0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups.QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.Copyright © 2024. Published by Elsevier Inc.

基金：
Medical writing support was provided by Sujia Wu, MD (a medical writer at Qilu Pharmaceutical Co., Ltd.) according to Good Publication Guidelines
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外文
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中科院(CAS)分区：
出版当年[2025]版：
大类 | 2 区 医学
小类 | 1 区 眼科学
最新[2025]版：
大类 | 2 区 医学
小类 | 1 区 眼科学
JCR分区：
出版当年[2023]版：
Q1 OPHTHALMOLOGY
最新[2024]版：
Q1 OPHTHALMOLOGY

影响因子： 最新[2024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] 出版后一年[2024版]

第一作者：
第一作者机构： [1]Department ofOphthalmology, University Hospital Kralovske Vinohrady,Prague, Czech Republic.
通讯作者：
推荐引用方式(GB/T 7714)：
Jan Hamouz,Agnieszka Nowosielska,Anna Święch-Zubilewicz,et al.Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration: A Phase 3 Randomized Trial[J].Ophthalmology. Retina.2025,9(4):343-351.doi:10.1016/j.oret.2024.10.001.
APA：
Jan Hamouz,Agnieszka Nowosielska,Anna Święch-Zubilewicz,Santiago Abengoechea,Kristine Baumane...&Wenbin Wei.(2025).Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration: A Phase 3 Randomized Trial.Ophthalmology. Retina,9,(4)
MLA：
Jan Hamouz,et al."Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration: A Phase 3 Randomized Trial".Ophthalmology. Retina 9..4(2025):343-351

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