康柏西普不同玻璃体腔注射方案治疗湿性年龄相关性黄斑变性的疗效及安全性比较

doi:10.3760/cma.j.cn115909-20201114-00439

Abstract
Figure/Table
References (29)
Related Citation (15)

Download: PDF (734 KB) HTML (1 KB)
Export: BibTeX | EndNote (RIS) Supporting Info

Guide

Abstract Objective: To assess the clinical effectiveness of an intravitreal injection of conbercept using two different strategies, the 3+PRN and 3+Q3M strategies, for the treatment of wet age-related macular degeneration (AMD). Methods: Prospective clinical study. Patients at Qilu Hospital, Shandong University who were confirmed to have exudative AMD from August 2018 to August 2019 were included. Exudative lesions of choroidal neovascularization (CNV) in the macular area were found in all 106 eyes of these patients. The international standard decimal visual acuity chart was used to measure best corrected visual acuity (BCVA). This was converted to the logarithm of the minimum angle of resolution (LogMAR) for the analysis. Optical coherence tomography (OCT) was used to measure central retinal thickness (CRT). For all eyes, an intravitreal injection of 0.5 mg of conbercept was administered with one of two strategies: 55 eyes received once monthly injections for the first 3 months, then 3+prore nata (3+PRN), and 51 eyes received once monthly injections for the first 3 months, followed by one injection every 3 months (3+Q3M). The patients were followed up for 12 months after the treatment. Routine examinations of BCVA, intraocular pressure (IOP), and OCT were conducted at 1 and 2 weeks after the operation, then these examinations were conducted every month. FFA examination was conducted every 3 months after the operation.The changes in BCVA, CRT and exudation of CNV lesions of the eyes were measured before and after treatment. Repeated measures analysis of variance was used to compare the groups and show the time effect, while the LSD t-test was used for comparisons among different time points within the same group. Results: The mean BCVA in both groups improved significantly at 1, 3, 6, 9 and 12 months after the operation, compared to the levels before treatment (3+PRN: t=7.202, 11.178, 9.914, 9.869, 10.587, respectively, P<0.001; 3+Q3M: t=5.548, 9.780, 9.358, 11.884, 11.622, respectively, P<0.001). In addition, the BCVA of the eyes was also significantly better in the 3+Q3M group than in the 3+PRN group at 9 and 12 months after the operation (t=2.304, P=0.023; t=2.058, P=0.042). The mean CRT of the eyes was significantly lower at 1, 3, 6, 9 and 12 months after treatment, compared to the level before treatment (3+PRN: t=12.28, 17.041, 17.615, 15.739, 16.171, P<0.001; 3+Q3M: t=10.221, 15.598, 16.297, 16.984, 17.275, P<0.001). In addition, the CRT of the eyes was significantly lower in the 3+Q3M group than in the 3+PRN group at 9 and 12 months after the operation (t=2.032, P=0.045; t=2.092, P=0.039). The FFA and ICGA examinations at the last follow-up showed that the exudation of CNV lesions in the macular area disappeared, reduced, or increased in 31(56%), 18(33%), and 6(11%) eyes in the 3+PRN group, and in 32(63%), 15(29%), and 4(8%) eyes in the 3+Q3M group, respectively. The Chi-square test shows the difference has no significance. There were no serious treatment-related ocular complications, such as retinal detachment, retinal tear, persistent intraocular pressure increase, or endophthalmitis, as well as serious systemic adverse responses found during the follow-up. Conclusions: Both strategies, namely the 3+PRN and 3+Q3M strategies, of intravitreal injection of conbercept are effective in treating wet AMD. However, the 3+Q3M strategy needs more injections but is more effective for improving visual acuity, reducing macular CRT thickness, and decreasing the exudation area of CNV, than the 3+PRN strategy.

Key words： conbercept wet age-related macular degeneration best corrected visual acuity central retinal thickness

Received: 14 November 2020

PACS:

Fund:

Corresponding Authors: Hong Wang, Department of Ophthalmology, Qilu Hospital, Shandong University, Jinan 250012, China (Email: dr.wanghong@163.com)

	Service

	E-mail this article
	Add to my bookshelf
	Add to citation manager
	E-mail Alert
	RSS
	Articles by authors

Cite this article:

URL:

https://www.cjoovs.com/EN/ 10.3760/cma.j.cn115909-20201114-00439 OR https://www.cjoovs.com/EN/Y2021/V23/I4/260

[1]	Ferris FL 3rd, Wilkinson CP, Bird A, et al. Clinical classification of age-related macular degeneration. Ophthalmology, 2013, 120(4): 844-851. DOI: 10.1016/j.ophtha.2012.10.036.
[2]	Ueta T, Noda Y, Toyama T, et al. Systemic vascular safety of ranibizumab for age-related macular degeneration: Systematic review and meta-analysis of randomized trials. Ophthalmology, 2014, 121(11): 2193-2203. DOI: 10.1016/j.ophtha.2014.05.022.
[3]	Vedula SS, Krzystolik MG. Antiangiogenic therapy with antivascular endothelial growth factor modalities for neovascular age-related macular degeneration. Cochrane Database Syst Rev, 2008, 2: CD005139. DOI: 10.1002/14651858.CD005139.pub2.
[4]	Kunimoto D, Yoon YH, Wykoff CC, et al. Efficacy and safety of abicipar in neovascular age-related macular degeneration: 52-week results of phase 3 randomized controlled study. Ophthalmology, 2020, 127(10): 1331-1344. DOI: 10.1016/ j.ophtha.2020.03.035.
[5]	Cui J, Sun D, Lu H, et al. Comparison of effectiveness and safety between conbercept and ranibizumab for treatment of neovascular age-related macular degeneration. A retrospective case-controlled non-inferiority multiple center study. Eye (Lond), 2018, 32(2): 391-399. DOI: 10.1038/eye.2017.187.
[6]	Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology, 2012, 119(12): 2537-2548. DOI: 10.1016/ j.ophtha.2012.09.006.
[7]	Wu L, Martínez-Castellanos MA, Quiroz-Mercado H, et al. Twelve-month safety of intravitreal injections of bevacizumab (Avastin): Results of the Pan-American Collaborative Retina Study Group (PACORES). Graefes Arch Clin Exp Ophthalmol, 2008, 246(1): 81-87. DOI: 10.1007/s00417-007-0660-z.
[8]	Danis P. Imaging data from the phase 3 clinical trial of conbercept in neovascular AMD. Miami: Angiogenesis, Exudation, and Degeneration USA: Miami. FL 2014.
[9]	中华医学会眼科学分会眼底病学组中国年龄相关性黄斑变性临. 中国年龄相关性黄斑变性临床诊断治疗路径. 中华眼底病杂志, 2013, 29(4): 343-355. DOI: 10.3760/cma. j.issn.1005-1015.2013.04.002.
[10]	Guymer RH, Markey CM, McAllister IL, et al. Tolerating subretinal fluid in neovascular age-related macular degeneration treated with ranibizumab using a treat-and-extend regimen: FLUID study 24-month results. Ophthalmology, 2019, 126(5): 723-734. DOI: 10.1016/j.ophtha.2018.11.025.
[11]	Jacob J, Brié H, Leys A, et al. Six-year outcomes in neovascular age-related macular degeneration with ranibizumab. Int J Ophthalmol, 2017, 10(1): 81-90. DOI: 10.18240/ijo.2017.01.14.
[12]	Singer MA, Awh CC, Sadda S, et al. HORIZON: An openlabel extension trial of ranibizumab for choroidal neovascu Iarization secondary to age-related macular degeneration. Ophthalmology,2012, 119(6): 1175-1183. DOI: 10.1016/j.ophtha.2011.12.016.
[13]	Rofagha S, Bhisitkul RB, Boyer DS, et al. Seven-year outcomes in ranibizumab-treated patients in ANCHOR, MARINA And HORIZON: A muhicenter cohort study (SEVEN-UP). Ophthalmology, 2013, 120(11): 2292-2299. DOI: 10.1016/ j.ophtha.2013.03.046.
[14]	Lalwani GA, Rosenfeld PJ, Fung AE, et al. A variable-dosing regimen with intravitreal ranibizumab for neovascular agerelated macular degeneration: Year 2 of the PRONTO Study. Am J Ophthalmol, 2009, 148(1):43-58. DOI: 10.1016/ j.ajo.2009.01.024.
[15]	Cvetkova NP, Hölldobler K, Prahs P, et al. Ranibizumab in neovascular age-related macular degeneration: A 5-year followup. Clin Ophthalmol, 2016, 8(10): 1047-1051. DOI: 10.2147/ OPTH.S101050.eCollection 2016.
[16]	Liu K, Song Y, Xu G, et al. Conbercept for treatment of neovascular age-related macular degeneration: Results of the randomized phase 3 PHOENIX study. Am J Ophthalmol, 2018, 197(8): 156-167. DOI: 10.1016/j.ajo.2018.08.026.
[17]	Chakravarthy U, Harding SP, Rogers CA, et al. Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial. Lancet, 2013, 382(9900): 1258-1267. DOI: 10.1016/S0140-6736(13)61501-9.
[18]	Benisek DA, Manzitti J, Scorsetti D, et al. Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere® ) in patients with neovascular age-related macular degeneration. Exp Ther Med, 2020, 20(6): 162. DOI: 10.3892/ etm.2020.9291.
[19]	Kaiser PK, Blodi BA, Shapiro H, et al. Angiographic and optical coherence tomographic results of the MARINA study of ranibizumab in neovascular age-related macular degeneration. Ophthalmology, 2007, 114(10): 1868-1875. DOI: 10.1016/ j.ophtha.2007.04.030.
[20]	Fung AE, Lalwani GA, Rosenfeld PJ, et al. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol, 2007, 143(4): 566-583. DOI: 10.1016/j.ajo.2007.01.028.
[21]	Silva R, Berta A, Larsen M, et al. Treat-and-extend versus monthly regimen in neovascular age-related macular degeneration: Results with ranibizumab from the TREND study. Ophthalmology, 2018, 125(1): 57-65. DOI: 10.1016/ j.ophtha.2017.07.014.
[22]	Li X, Xu G, Wang Y, et al. Safety and efficacy of conbercept in neovascular age-related macular degeneration: results from a 12-month randomized phase 2 study: AURORA study. Ophthalmology, 2014, 121(9): 1740-1747. DOI: 10.1016/ j.ophtha.2014.03.026.
[23]	Regillo CD, Brown DM, Abraham P, et al. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1. Am J Ophthalmol, 2008, 145(2): 239-248. DOI: 10.1016/j.ajo.2007. 10.004.
[24]	Muether PS, Hermann MM, Dröge K, et al. Long-term stability of vascular endothelial growth factor suppression time under ranibizumab treatment in age-related macular degeneration. Am J Ophthalmol, 2013, 156(5): 989-993. DOI: 10.1016/ j.ajo.2013.06.020.
[25]	Fauser S, Schwabecker V, Muether PS. Suppression of intraocular vascular endothelial growth factor during aflibercept treatment of age-related macular degeneration. Am J Ophthalmol, 2014, 158(3): 532-536.DOI: 10.1136/ bjophthalmol-2015-308264.
[26]	Kvannli L, Krohn J. Switching from pro re nata to treatand-extend regimen improves visual acuity in patients with neovascular age-related macular degeneration. Acta Ophthalmol, 2017, 95(7): 678-682. DOI: 10.1111/aos.13356.
[27]	Stem MS, Rao P, Lee IJ, et al. Predictors of endophthalmitis after intravitreal injection: A multivariable analysis based on injection protocol and povidone iodine strength. Ophthalmol Retina, 2019, 3(1): 3-7. DOI: 10.1016/j.oret.2018.09.013.
[28]	Severn PS, Hamilton R. The incidence of serious complications associated with intravitreal therapy in a quaternary ARMD service (2008-2014). Eye (Lond), 2015, 29(1): 150. DOI: 10.1038/eye.2014.231.
[29]	Du L, Peng H, Wu Q, et al. Observation of total VEGF level in hyperglycemic mouse eyes after intravitreal injection of the novel anti-VEGF drug conbercept. Mol Vis, 2015, 21: 185-193.

[1]	. [J]. Chinese Journal of Optometry Ophthalmology and Visual science, 2023, 25(8): 0-.