Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy (RANTA)
Multicenter Randomized Controlled Study of Intravitreal Ranibizumab and Triamcinolone Acetonide Combination Therapy Versus Ranibizumab Monotherapy in Patients With Polypoidal Choroidal Vasculopathy
研究概览
详细说明
Polypoidal choroidal vasculopathy (PCV), a vascular disease of the choroid, appears to be the predominant subtype of exudative or "wet" AMD in Asian populations, in contrast to choroidal neovascularization secondary to AMD (CNV-AMD) in Western populations. There are distinct differences in pathophysiological, clinical and epidemiological factors between the two subtypes, although they also share some common risk factors. In contrast to CNV-AMD, PCV does not seem to respond as well to anti-VEGF treatment. The optimal treatment option for PCV remains elusive, with most studies showing good short-term visual outcome but poorer longer-term outcome with current treatment strategies. Therefore, understanding the pathogenesis of PCV, while developing novel and effective treatments strategies to prevent PCV-related vision loss is significant unmet needs.
The purpose of this study is to assess the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with PCV. Second, the pharmacogenetics effect of inflammatory related genes and polymorphism in response to the treatments of PCV will be explored. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV, it is important to determine the levels of inflammatory factors in the anterior chamber aqueous humor from PCV patients, comparing with the aqueous humor acquired from the age-matched age-related cataract patients undergoing phacoemulsification.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国
- Beijing Aier Intech Eye Hospital
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Guangdong
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Guanzhou、Guangdong、中国
- Guangzhou Aier Eye Hospital
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Shenzhen、Guangdong、中国、510000
- Shenzhen Aier Eye Hospital
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Shenzhen、Guangdong、中国、528000
- Shenzhen Eye Hospital
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Heilongjiang
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Harbin、Heilongjiang、中国
- Harbin Aier Eye Hospital
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Hubei
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Wuhan、Hubei、中国
- Wuhan General Hospital of Pla
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Zhejiang
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Wenzhou、Zhejiang、中国、325027
- The Eye Hospital of Wenzhou Medical University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- bestcorrected visual acuity (BCVA) letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts at a starting distance of 4 m (20/40 to 20/320 Snellen equivalent);
- a greatest lineardimensionof the lesion of <5400 um( 9 Macular Photocoagulation Study disk areas), assessed by ICGA;
- Cross-reading by different center to confirmed diagnosis of PCV, that is, presence of early subretinal focal ICGA hyperfluorescence (appearing within the first 6 minutes after injection of indocyanine green) and in addition, at least one of the following angiographic or clinical criteria: (i) association with a BVN, (ii) presence of pulsatile polyp, (iii) nodular appearance when viewed stereoscopically, (iv) presence of hypofluorescent halo (in first 6 minutes),7 (v) orange subretinal nodules in stereoscopic color fundus photograph (polyp corresponding to ICGA lesions), or (vi) association with massive submacular hemorrhage (defined as size of hemorrhage of at least 4 disk areas).
Exclusion Criteria:
- received treatment previously with verteporfin PDT, focal laser photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood, or any investigational treatment;
- a history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia;
- experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma;
- undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation within 60 days before the screening visit)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Ranibizumab + Triamcinolone Acetonide
intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg
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Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.
其他名称：
Intravitreal inject 0.5mg of Ranibizumab.
其他名称：
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有源比较器：Ranibizumab
intravitreal injection: Ranibizumab 0.5mg
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Intravitreal inject 0.5mg of Ranibizumab.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of mean BCVA
大体时间：12 months
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Change of Central BCVA (Measured with EDTRS Chart,numbers of letters) (primary: baseline and 6 months, secondary: baseline to 12 months)
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of Central Rerina Thickness
大体时间：12 months
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Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months)
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12 months
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regression of Branch vacular network(BVN)
大体时间：12 months
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Size of Branch vascular network (um)
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12 months
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Polyps regression
大体时间：12 months
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Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months)
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12 months
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Number of re-treatments
大体时间：12 month
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re-treatments numbers
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12 month
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合作者和调查者
调查人员
- 学习椅：Shibo Tang、Aier School of Ophthalmology, Central South University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Triamcinolone Acetonide的临床试验
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Johns Hopkins University撤销
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Johns Hopkins UniversityAlimera Sciences; pSiVida Limited完全的
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Alimera SciencesCBCC Global Research招聘中
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Centre Hospitalier Universitaire Dijon招聘中