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Abstract：
BACKGROUND: Intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) drugs have been widely used in patients with macular edema (ME) secondary to retinal vein occlusion (RVO); however, recurrence is a major concern. This study aims to observe the clinical effects of atorvastatin and intravitreal therapy in the treatment of patients with branch or central RVO-ME and coexistent carotid plaques (CP).
METHODS: A prospective randomized controlled clinical trial will be conducted. Sixty-four patients diagnosed with branch or central RVO-ME and coexistent CP will be enrolled and randomly allocated in a 1:1 ratio to the control and experimental groups. The control group will be treated with intravitreal conbercept monthly for 3 months, followed by monthly evaluation and injection of pro re nata (PRN) for 12 months, while the experimental group will be treated with oral atorvastatin 20 mg daily combined with the control group treatment. If a drop of best-corrected visual acuity (BCVA) is more than five Early Treatment Diabetic Retinopathy Study (ETDRS) letters (one line) or an increment in central subfield thickness (CSFT) of 100 μm (or a 10% increment from the previous visit), intravitreal re-treatment will be performed. Outcome measurements include CSFT, BCVA, number of injections, and incidence of adverse events during the 12-month follow-up period. Differences between groups will be evaluated using Student\'s t-test, and comparisons between groups will be evaluated using repeated-measures analysis of variance.
BACKGROUND: The study has been approved by the Institutional Review Board of Nanjing Lishui People\'s Hospital, Nanjing, China (approval number 2023KY0418-12, dated 18 April 2023), and has been registered on chictr.org.cn. Written informed consent will be collected from each patient and the results of this trial will be submitted to a peer-reviewed journal.
BACKGROUND: Chinese Clinical Trial Registry ChiCTR2300071359. Registered on 12 May 2023.
METHODS: A prospective randomized controlled clinical trial will be conducted. Sixty-four patients diagnosed with branch or central RVO-ME and coexistent CP will be enrolled and randomly allocated in a 1:1 ratio to the control and experimental groups. The control group will be treated with intravitreal conbercept monthly for 3 months, followed by monthly evaluation and injection of pro re nata (PRN) for 12 months, while the experimental group will be treated with oral atorvastatin 20 mg daily combined with the control group treatment. If a drop of best-corrected visual acuity (BCVA) is more than five Early Treatment Diabetic Retinopathy Study (ETDRS) letters (one line) or an increment in central subfield thickness (CSFT) of 100 μm (or a 10% increment from the previous visit), intravitreal re-treatment will be performed. Outcome measurements include CSFT, BCVA, number of injections, and incidence of adverse events during the 12-month follow-up period. Differences between groups will be evaluated using Student\'s t-test, and comparisons between groups will be evaluated using repeated-measures analysis of variance.
BACKGROUND: The study has been approved by the Institutional Review Board of Nanjing Lishui People\'s Hospital, Nanjing, China (approval number 2023KY0418-12, dated 18 April 2023), and has been registered on chictr.org.cn. Written informed consent will be collected from each patient and the results of this trial will be submitted to a peer-reviewed journal.
BACKGROUND: Chinese Clinical Trial Registry ChiCTR2300071359. Registered on 12 May 2023.
摘要：
背景：玻璃体内注射抗血管内皮生长因子（抗VEGF）药物已广泛用于视网膜静脉阻塞（RVO）继发黄斑水肿（ME）的患者；然而，复发是一个主要问题。本研究旨在观察阿托伐他汀联合玻璃体腔治疗分支或中心性RVO-ME并共存颈动脉斑块(CP)患者的临床疗效。
方法：将进行前瞻性随机对照临床试验。将纳入64例诊断为分支或中央RVO-ME和共存CP的患者，并以1：1的比例随机分配给对照组和实验组。对照组将接受玻璃体腔康柏西普每月治疗3个月，然后每月评估和注射prorenata（PRN）12个月，而实验组则采用口服阿托伐他汀20mg/d联合对照组治疗。如果最佳矫正视力（BCVA）下降超过五个早期治疗糖尿病视网膜病变研究（ETDRS）字母（一条线）或中央子场厚度（CSFT）增加100μm（或从上次就诊增加10％），将进行玻璃体内再治疗。结果测量包括CSFT，BCVA,注射次数,以及12个月随访期间的不良事件发生率。组间差异将使用学生t检验进行评估，和组间比较将使用重复测量方差分析进行评估。
背景：该研究已获得南京市丽水市人民医院机构审查委员会的批准，南京,中国（批准号2023KY0418-12，日期为2023年4月18日），并已在chictr.org上注册。cn.将收集每位患者的书面知情同意书，并将该试验的结果提交给同行评审的期刊。
背景：中国临床试验注册ChiCTR2300071359。2023年5月12日注册。
方法：将进行前瞻性随机对照临床试验。将纳入64例诊断为分支或中央RVO-ME和共存CP的患者，并以1：1的比例随机分配给对照组和实验组。对照组将接受玻璃体腔康柏西普每月治疗3个月，然后每月评估和注射prorenata（PRN）12个月，而实验组则采用口服阿托伐他汀20mg/d联合对照组治疗。如果最佳矫正视力（BCVA）下降超过五个早期治疗糖尿病视网膜病变研究（ETDRS）字母（一条线）或中央子场厚度（CSFT）增加100μm（或从上次就诊增加10％），将进行玻璃体内再治疗。结果测量包括CSFT，BCVA,注射次数,以及12个月随访期间的不良事件发生率。组间差异将使用学生t检验进行评估，和组间比较将使用重复测量方差分析进行评估。
背景：该研究已获得南京市丽水市人民医院机构审查委员会的批准，南京,中国（批准号2023KY0418-12，日期为2023年4月18日），并已在chictr.org上注册。cn.将收集每位患者的书面知情同意书，并将该试验的结果提交给同行评审的期刊。
背景：中国临床试验注册ChiCTR2300071359。2023年5月12日注册。
