Evidence map›Paper›PMID 37987893›Full record

ArticleOphthalmology and therapy2024

Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial.

Bing Li, Ke Fan, Tonghe Zhang, Zhifeng Wu, Siming Zeng, Mingwei Zhao, Qian Ren, Dongping Zheng, Lifei Wang, Xiaoling Liu and 30 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05345236 (A Phase III Randomised, Double-masked, Parallel Group Study to Compare the Efficacy and Safety Between QL1207), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05345236 phase3completednot on this map

A Phase III Randomised, Double-masked, Parallel Group Study to Compare the Efficacy and Safety Between QL1207 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Wet Age-related Macular Degeneration

TypeinterventionalSponsorQilu Pharmaceutical Co., Ltd.Ran2019 to 2022Enrolled366ConditionsWet Age-related Macular DegenerationArmsAflibercept
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

40 authors.

Bing Li *Ophthalmology Department, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing, 100730, China.
Ke Fan *Ophthalmology Department, Henan Provincial Eye Hospital, Zhengzhou, China.
Tonghe ZhangOphthalmology Department, Jinan Second People's Hospital, Jinan, China.
Zhifeng WuOphthalmology Department, Wuxi Second People's Hospital, Wuxi, China.
Siming ZengOphthalmology Department, Guangxi Zhuang Autonomous Region People's Hospital, Nanning, China.
Mingwei ZhaoOphthalmology Department, Peking University People's Hospital, Beijing, China.
Qian RenOphthalmology Department, Shijiazhuang People's Hospital, Shijiazhuang, China.
Dongping ZhengOphthalmology Department, Shanxi Ophthalmic Hospital, Taiyuan, China.
Lifei WangOphthalmology Department, Hebei Eye Hospital, Xingtai, China.
Xiaoling LiuOphthalmology Department, Eye Hospital, WMU Zhejiang Eye Hospital, Wenzhou, China.
Mei HanOphthalmology Department, Tianjin Eye Hospital, Tianjin, China.
Yanping SongOphthalmology Department, General Hospital of Central Theater Command, Wuhan, China.
Jian YeOphthalmology Department, Army Medical Center of PLA, Chongqing, China.
Cheng PeiOphthalmology Department, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Jinglin YiOphthalmology Department, Affiliated Eye Hospital of Nanchang University, Nanchang, China.
Xian WangOphthalmology Department, The Affiliated Hospital of Guizhou Medical University, Guiyang, China.
Hui PengOphthalmology Department, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Hong ZhangOphthalmology Department, The First Affiliated Hospital of Harbin Medical University, Harbin, China.
Zhanyu ZhouOphthalmology Department, Qingdao Municipal Hospital, Qingdao, China.
Xiaoling LiangOphthalmology Department, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.
Fangliang YuOphthalmology Department, The First Hospital of Nanchang, Nanchang, China.
Miaoqin WuOphthalmology Department, Zhejiang Provincial People's Hospital, Hangzhou, China.
Chaopeng LiOphthalmology Department, Huai'an First People's Hospital, Huai'an, China.
Chunling LeiOphthalmology Department, Xi'an People's Hospital, Xi'an, China.
Jilong HaoOphthalmology Department, First Hospital of Jilin University, Changchun, China.
Luosheng TangOphthalmology Department, The Second Xiangya Hospital of Center South University, Changsha, China.
Huiping YuanOphthalmology Department, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.
Shanjun CaiOphthalmology Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.
Qiuming LiOphthalmology Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Jingxiang ZhongOphthalmology Department, The First Affiliated Hospital of Jinan University, Guangzhou, China.
Suyan LiOphthalmology Department, Xuzhou First People's Hospital, Xuzhou, China.
Lin LiuOphthalmology Department, Renji Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China.
Min KeOphthalmology Department, Wuhan University Zhongnan Hospital, Wuhan, China.
Jing WangClinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.
Hui WangClinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.
Mengli ZhuClinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.ORCID http://orcid.org/0009-0007-3840-8799
Zenghua WangClinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.
Yang YanClinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.
Feng WangOphthalmology Department, The Second Affiliated Hospital of Xi'an Jiaotong University, No. 157, Xiwu Road, Xincheng District, Xi'an, 710004, China. wfoculist@126.com.
Youxin ChenOphthalmology Department, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing, 100730, China. chenyx@pumch.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis trial aimed to compare the efficacy and safety between biosimilar QL1207 and the reference aflibercept for the treatment of neovascular age-related macular degeneration (nAMD).

methodsThis randomized, double-blind, phase 3 trial was conducted at 35 centers in China. Patients aged ≥ 50 years old with untreated subfoveal choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA) letter score of 73-34 were eligible. Patients were randomly assigned to receive intravitreous injections of QL1207 or aflibercept 2 mg (0.05 ml) in the study eye every 4 weeks for the first 3 months, followed by 2 mg every 8 weeks until week 48, stratified by baseline BCVA ≥ or < 45 letters. The primary endpoint was BCVA change from baseline at week 12. The equivalence margin was ± 5 letters. The safety, immunogenicity, pharmacokinetics (PK), and plasma vascular endothelial growth factor (VEGF) concentration were also evaluated.

resultsA total of 366 patients were enrolled (QL1207 group, n = 185; aflibercept group, n = 181) from Aug 2019 to Jan 2022 with comparable baseline characteristics. The least-squares mean difference in BCVA changes was - 1.1 letters (95% confidence interval - 3.0 to 0.7; P = 0.2275) between the two groups, within the equivalence margin. The incidences of treatment-emergent adverse events (TEAE; QL1207: 71.4% [132/185] vs. aflibercept: 71.8% [130/181]) and serious TEAE (QL1207: 14.1% [26] vs. aflibercept: 12.7% [23]) appeared comparable between treatment groups, and no new safety signal was found. Anti-drug antibody, PK profiles, and VEGF concentration were similar between the two groups.

conclusionsQL1207 has equivalent efficacy to aflibercept for nAMD with similar safety profiles. It could be used as an alternative anti-VEGF agent for clinical practice.

trial registrationClinicalTrials.gov: NCT05345236 (retrospectively registered on April 25, 2022); National Medical Products Administration of China: CTR20190937 (May 20, 2019).

Indexed as

AfliberceptBiosimilarNeovascular age-related macular degenerationQL1207

Identifiers

PMID37987893
PMCPMC10776547

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.