Kun Liu1, Yanping Song2, Gezhi Xu3, Jian Ye4, Zhifeng Wu5, Xiaoling Liu6, Xiaoguang Dong7, Mingzhi Zhang8, Yiqiao Xing9, Shaoping Zhu1, Xia Chen1, Yinchen Shen1, Hengye Huang10, Liyun Yu11, Zunhong Ke11, Philip J Rosenfeld12, Peter K Kaiser13, Guishuang Ying14, Xiaodong Sun1, Xun Xu15. 1. Department of Ophthalmology, Shanghai Key Laboratory of Ocular Fundus Diseases, Shanghai General Hospital, Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai, China. 2. Department of Ophthalmology, Wuhan General Hospital of Guangzhou Military, Wuhan, Hubei, China. 3. Department of Ophthalmology, Eye & ENT Hospital of Fudan University, Shanghai, China. 4. Department of Ophthalmology, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing, China. 5. Department of Ophthalmology, Wuxi No. 2 People's Hospital, Nanjing Medical University, Wuxi, Jiangsu, China. 6. School of Optometry and Ophthalmology and Eye Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, China. 7. Department of Ophthalmology, Qingdao Eye Hospital, Shandong Eye Institute, Qingdao, Shandong, China. 8. Joint Shantou International Eye Centre, Shantou, Guangdong, China. 9. Department of Ophthalmology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China. 10. School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China. 11. Company, Chengdu Kanghong Biotechnology Inc, Chengdu, Sichuan, China. 12. Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA. 13. Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA. 14. Department of Ophthalmology, Center for Preventative Ophthalmology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA. 15. Department of Ophthalmology, Shanghai Key Laboratory of Ocular Fundus Diseases, Shanghai General Hospital, Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai, China. Electronic address: drxuxun@sjtu.edu.cn.
Abstract
PURPOSE: Age-related macular degeneration (AMD) can cause irreversible vision loss leading to blindness. We aim to evaluate the efficacy and safety of intravitreal injections of 0.5 mg conbercept, a new anti-vascular endothelial growth factor (anti-VEGF) drug, for treatment of AMD on a schedule more manageable for patients. DESIGN: A prospective, double-masked, multicenter, sham-controlled, phase III randomized trial. METHODS:Patients: Patients with choroidal neovascularization (CNV) secondary to AMD were enrolled and randomized to the conbercept group or the sham control group. INTERVENTION: The conbercept group received intravitreal injections of conbercept (0.5 mg) once monthly for the first 3 months, then once quarterly until month 12 (3 + Q3M). The sham group received first 3 monthly sham injections and then 3 monthly injections of conbercept (0.5 mg) followed by quarterly administrations until month 12. MAIN OUTCOME MEASURES: The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at month 3. RESULTS: A total of 114 patients (91.9%) from 9 sites in China completed the 12-month study. At the 3-month primary endpoint, the mean changes in BCVA from baseline were +9.20 letters in the conbercept group and +2.02 letters in the sham group, respectively (P < .001). At 12 months, the mean changes from baseline in BCVA letter score were +9.98 letters in the conbercept group and +8.81 letters in the sham group (P = .64). The most common ocular adverse events were associated with intravitreal injections, such as conjunctival hemorrhage, and increased intraocular pressure. CONCLUSIONS: A conbercept dosing regimen of 3 initial monthly administrations followed by quarterly treatments is effective for treatment of AMD. In previous reports, other anti-VEGF agents were unable to maintain similar clinical benefits with the same regimen.
RCT Entities:
PURPOSE:Age-related macular degeneration (AMD) can cause irreversible vision loss leading to blindness. We aim to evaluate the efficacy and safety of intravitreal injections of 0.5 mg conbercept, a new anti-vascular endothelial growth factor (anti-VEGF) drug, for treatment of AMD on a schedule more manageable for patients. DESIGN: A prospective, double-masked, multicenter, sham-controlled, phase III randomized trial. METHODS:Patients: Patients with choroidal neovascularization (CNV) secondary to AMD were enrolled and randomized to the conbercept group or the sham control group. INTERVENTION: The conbercept group received intravitreal injections of conbercept (0.5 mg) once monthly for the first 3 months, then once quarterly until month 12 (3 + Q3M). The sham group received first 3 monthly sham injections and then 3 monthly injections of conbercept (0.5 mg) followed by quarterly administrations until month 12. MAIN OUTCOME MEASURES: The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at month 3. RESULTS: A total of 114 patients (91.9%) from 9 sites in China completed the 12-month study. At the 3-month primary endpoint, the mean changes in BCVA from baseline were +9.20 letters in the conbercept group and +2.02 letters in the sham group, respectively (P < .001). At 12 months, the mean changes from baseline in BCVA letter score were +9.98 letters in the conbercept group and +8.81 letters in the sham group (P = .64). The most common ocular adverse events were associated with intravitreal injections, such as conjunctival hemorrhage, and increased intraocular pressure. CONCLUSIONS: A conbercept dosing regimen of 3 initial monthly administrations followed by quarterly treatments is effective for treatment of AMD. In previous reports, other anti-VEGF agents were unable to maintain similar clinical benefits with the same regimen.
Authors: Faruque Ghanchi; Rupert Bourne; Susan M Downes; Richard Gale; Christina Rennie; Ian Tapply; Sobha Sivaprasad Journal: Eye (Lond) Date: 2022-01-01 Impact factor: 4.456
Authors: Rehan M Hussain; Bilal A Shaukat; Lauren M Ciulla; Audina M Berrocal; Jayanth Sridhar Journal: Drug Des Devel Ther Date: 2021-06-21 Impact factor: 4.162