Evidence map›Paper›PMID 41448868›Full record

Trial reportThe British journal of ophthalmology2026

Efficacy and safety of anti-VEGF monoclonal antibody 601 for macular oedema in retinal vein occlusion: two phase IIa randomised clinical trials.

Shuo Zhao, Miaoqin Wu, Jingxiang Zhong, Baihua Chen, Zongming Song, Zhang Ming, Quanhong Han, Suqin Yu, Hong Wang, Songtao Yuan and 11 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The British journal of ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT04667897 phase2completednot on this map

A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

TypeinterventionalSponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Ran2021 to 2022Enrolled60ConditionsBranch Retinal Vein OcclusionArms601 1.25mg, Ranibizuman 0.5 mg
NCT04667910 phase2completednot on this map

A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

TypeinterventionalSponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Ran2021 to 2022Enrolled60ConditionsCentral Retinal Vein OcclusionArms601 1.25mg, Ranibizuman 0.5 mg
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

21 authors.

Shuo ZhaoDepartment of Ophthalmology, Beijing Hospital, National Center of Gerontology Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, Beijing, China.
Miaoqin WuDepartment of Ophthalmology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, Zhejiang, China.
Jingxiang ZhongDepartment of Ophthalmology, Jinan University First Affiliated Hospital, Guangzhou, Guangdong, China.
Baihua ChenDepartment of Ophthalmology, The Second Xiangya Hospital of Central South University, Changsha, China.
Zongming SongDepartment of Ophthalmology, People's Hospital of Henan University, Henan Provincial People's Hospital, Henan Eye Hospital, Henan Key Laboratory of Ophthalmology, Henan Academy of Innovations in Medical Science, Zhengzhou, Henan, China.
Zhang MingDepartment of Ophthalmology, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
Quanhong HanTianjin Eye Hospital, Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, Tianjin, China.ORCID http://orcid.org/0000-0003-3502-9607
Suqin YuDepartment of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Eye Diseases, Shanghai Clinical Research Center for Eye Diseases, Shanghai, Shanghai, China.
Hong WangDepartment of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Eye Diseases, Shanghai Clinical Research Center for Eye Diseases, Shanghai, Shanghai, China.
Songtao YuanDepartment of Ophthalmology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Jin YaoDepartment of Ophthalmology, The Affiliated Eye Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.ORCID http://orcid.org/0000-0003-4617-5394
Mingwei ZhaoDepartment of Ophthalmology, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, College of Optometry, Peking University Health Science Center, Beijing, Beijing, China.
Xiaohong MengDepartment of Ophthalmology, The Southwest Hospital of AMU, Chongqing, Chongqing, China.
Feng WangDepartment of Ophthalmology, Xi'an Jiaotong University Second Affiliated Hospital, Xi'an, Shaanxi, China.
Jing LouSunshine Guojian Pharmaceutical Shanghai Co Ltd, Shanghai, Shanghai, China.
Yanli LiuSunshine Guojian Pharmaceutical Shanghai Co Ltd, Shanghai, Shanghai, China.
Haomin HuangSunshine Guojian Pharmaceutical Shanghai Co Ltd, Shanghai, Shanghai, China.
Qinghong ZhouSunshine Guojian Pharmaceutical Shanghai Co Ltd, Shanghai, Shanghai, China.
Yuyu XuSunshine Guojian Pharmaceutical Shanghai Co Ltd, Shanghai, Shanghai, China.
Hong DaiDepartment of Ophthalmology, Beijing Hospital, National Center of Gerontology Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, Beijing, China xiaorli@163.com dai-hong@x263.net.
Xiaorong LiTianjin Medical University Eye Hospital, Tianjin, China xiaorli@163.com dai-hong@x263.net.ORCID http://orcid.org/0000-0003-0641-2797

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile anti-vascular endothelial growth factor (VEGF) therapies are effective for macular oedema secondary to retinal vein occlusion (RVO), there remains a need for additional treatment options. This study evaluated the novel anti-VEGF agent 601 versus ranibizumab in patients with branch RVO (BRVO) or central RVO (CRVO).

methodsIn two multicentre, randomised, double-masked, active-controlled phase IIa trials (NCT04667897, NCT04667910) conducted at 12 Chinese sites (2021-2022), 120 patients were assigned 1:1 to receive intravitreal 1.25 mg 601 or 0.5 mg ranibizumab every 4 weeks until week 20, followed by pro re nata dosing through week 48. Eligible patients had best-corrected visual acuity (BCVA) of 78-19 Early Treatment Diabetic Retinopathy Study letters and central subfield thickness ≥250 µm. The primary endpoint was change in BCVA at week 24.

resultsAt week 24, the adjusted mean BCVA change from baseline was +16.52 letters for 601 versus +17.79 letters for ranibizumab (adjusted mean difference: -1.27 letters (95% CI -5.439 to 2.891 letters)) in BRVO, and +13.81 letters versus +16.79 letters (adjusted mean difference: -2.97 letters (95% CI -10.488 to 4.540 letters)) in CRVO. Central retina thickness (CST) reduction was similar for both treatments. Both groups showed sustained improvements from week 24 to 52 with similar adverse event profiles.

conclusionsThese trials demonstrate that 601 is as effective and safe as ranibizumab for improving vision and reducing CST in RVO-related macular oedema. Phase III trials are warranted.

Indexed as

Angiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedMacular EdemaRanibizumabRetinal Vein OcclusionAgedDouble-Blind MethodFemaleFluorescein AngiographyHumansIntravitreal InjectionsMaleMiddle AgedTomography, Optical CoherenceTreatment OutcomeAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedRanibizumabVascular Endothelial Growth Factor AClinical TrialIntraretinal FluidTreatment Medical

Identifiers

PMID41448868
PMCPMC13311981

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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.