Study on the Correlation Between the Treatment Effectiveness of Ranibizumab and the Role of the Cytokines in Macular Edema With Retinal Vein Occlusion
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual function by ranibizumab in macular edema with retnal vein occlusion
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by determining the pathogenesis of macular edema, which cause a direct effect on visual function. In particular, we focus on the correlation between the treatment effectiveness of ranibizumab and the role of the cytokines involved in the cause of macular edema.
详细描述
Methodology:
Aqueous humor samples (0.1ml) were obtained during intravitreous injection of ranibizumab to measure the levels of cytokines. Targeted cytokines are follows; IL-1, IL-2, IL-6, IL-8, IL-9, IL-10, IL-12, IL-13, IP-10, MCP-1, MMP-1, MIP-1β, PDGF, VEGF, PlGF, ICAM-1, TNF-α, RANTES, VEGFR-1, VEGFR-2, which has been reported that the expression level is increased in macular edema associated with RVO. Cytokines are measured by multiple ELISA (Luminex). Aqueous humor samples are obtained in the same manner from patients recurred after the first injection or continuous monthly injections. Statistical analysis is conducted to examine the difference of cytokine levels between early or late/incomplete responders of ranibizumab, and predict the number of injections to stabilize cytokine levels.
Number of centers & patients: Single center, 100 patients
Sample size justification: Sample size calculation was not done, since this study is a single-arm, observational study.
Population: Inclusion criteria: patients with RVO and macular edema
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Foveal thickness > 300 μm
- •Best corrected visual acuity < 20/30
排除标准
- •History of retinal diseases other than BRVO, glaucoma, uveitis, diabetes mellitus, rubeosis iridis, ocular infections, laser photocoagulation, and intraocular surgery
研究组 & 干预措施
ranibizumab
Experimental: Intravitreal injection of Ranibizumab
干预措施: ranibizumab (Drug)
结局指标
主要结局
Visual function by ranibizumab in macular edema with retnal vein occlusion
时间窗: one year
Mean change in central retinal thickness (CRT) and best corrected visual acuity (BCVA) at month 12
次要结局
- Cytokine levels by ranibizumab in macular edema with retnal vein occlusion(one year)
研究者
Hidetaka Noma
Department of Ophthalmology, Hachioji Medical Center
Tokyo Medical University