{
  "abstract": "Background While 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).Methods In 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.Results At 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.Conclusions These 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.",
  "authors": [
    {
      "affiliations": [
        "Department of Ophthalmology, Beijing Hospital, National Center of Gerontology Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, Beijing, China"
      ],
      "name": "Shuo Zhao"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Zhejiang Provincial People’s Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, Zhejiang, China"
      ],
      "name": "Miaoqin Wu"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Jinan University First Affiliated Hospital, Guangzhou, Guangdong, China"
      ],
      "name": "Jingxiang Zhong"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, The Second Xiangya Hospital of Central South University, Changsha, China"
      ],
      "name": "Baihua Chen"
    },
    {
      "affiliations": [
        "Department 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"
      ],
      "name": "Zongming Song"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, West China Hospital of Sichuan University, Chengdu, Sichuan, China"
      ],
      "name": "Zhang Ming"
    },
    {
      "affiliations": [
        "Tianjin Eye Hospital, Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, Tianjin, China"
      ],
      "name": "Quanhong Han"
    },
    {
      "affiliations": [
        "Department 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"
      ],
      "name": "Suqin Yu"
    },
    {
      "affiliations": [
        "Department 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"
      ],
      "name": "Hong Wang"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China"
      ],
      "name": "Songtao Yuan"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, The Affiliated Eye Hospital of Nanjing Medical University, Nanjing, Jiangsu, China"
      ],
      "name": "Jin Yao"
    },
    {
      "affiliations": [
        "Department 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"
      ],
      "name": "Mingwei Zhao"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, The Southwest Hospital of AMU, Chongqing, Chongqing, China"
      ],
      "name": "Xiaohong Meng"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Xi’an Jiaotong University Second Affiliated Hospital, Xi’an, Shaanxi, China"
      ],
      "name": "Feng Wang"
    },
    {
      "affiliations": [
        "Sunshine Guojian Pharmaceutical Shanghai Co Ltd, Shanghai, Shanghai, China"
      ],
      "name": "Jing Lou"
    },
    {
      "affiliations": [
        "Sunshine Guojian Pharmaceutical Shanghai Co Ltd, Shanghai, Shanghai, China"
      ],
      "name": "Yanli Liu"
    },
    {
      "affiliations": [
        "Sunshine Guojian Pharmaceutical Shanghai Co Ltd, Shanghai, Shanghai, China"
      ],
      "name": "Haomin Huang"
    },
    {
      "affiliations": [
        "Sunshine Guojian Pharmaceutical Shanghai Co Ltd, Shanghai, Shanghai, China"
      ],
      "name": "Qinghong Zhou"
    },
    {
      "affiliations": [
        "Sunshine Guojian Pharmaceutical Shanghai Co Ltd, Shanghai, Shanghai, China"
      ],
      "name": "Yuyu Xu"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Beijing Hospital, National Center of Gerontology Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, Beijing, China"
      ],
      "name": "Hong Dai"
    },
    {
      "affiliations": [
        "Tianjin Medical University Eye Hospital, Tianjin, China"
      ],
      "name": "Xiaorong Li"
    }
  ],
  "title": "Efficacy and safety of anti-VEGF monoclonal antibody 601 for macular oedema in retinal vein occlusion: two phase IIa randomised clinical trials",
  "uid": "77d12b4a-6328-551e-8a98-dbcf03e95781"
}