Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- Change in retinal thickness as measured in μm using spectral domain optical coherence tomography
研究概览
简要总结
Central retinal vein occlusion (CRVO) is a common retinal vascular disorder, occurring when there is a blockage to the main blood vessel that transports blood away from the retina. CRVO may cause visual impairment, especially due to macular edema (swelling of the macula due to fluid accumulation) and macular non-perfusion.
Aflibercept has been found to improve visual acuity and reduce macular thickness in pivotal trials.
The purpose of this study was to evaluate the efficacy and safety of intravitreal aflibercept in real-world, using a patient-fitted treatment regimen. Additionally, imaging parameters have been assessed before and after treatment with intravitreal aflibercept.
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
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Treatment naive center-involved macular edema secondary to CRVO for no longer than 3 months.
- •Patients >18 years of age, who are diagnosed with macular edema secondary to CRVO who are scheduled to be treated with intravitreal aflibercept in real-life conditions
- •BCVA of Snellen of 20/40 to 20/200 in the study eye
排除标准
- •Previous PRP or macular laser photocoagulation in the study eye.
- •Any prior ocular treatment in the study eye for macular edema secondary to CRVO.
- •Prior systemic anti-VEGF or corticosteroid therapy, within the last 3 months before enrollment to the study.
- •Any active or previous inflammation, ocular trauma
- •Uncontrolled glaucoma (IOP>30 mmHg)
研究组 & 干预措施
Eylea 2.0mg/0.05ml
干预措施: EYLEA 2 MG in 0.05 ML Injection (Drug)
结局指标
主要结局
Change in retinal thickness as measured in μm using spectral domain optical coherence tomography
时间窗: 5 years
Change in visual acuity as measured using ETDRS charts
时间窗: 5 years
次要结局
- Change in microvascular parameters in OCT angiography (vessel density, FAZ area)(2 years)
- Complications(5 years)
- Change in endothelial dysfunctionafter aflibercept treatment, as measured by the perfused boundary region sublingual 5-25 μm(6 months)
研究者
Irini Chatziralli
Associate Professor in Ophthalmology
National and Kapodistrian University of Athens