NCT03866746已完成4 期
Aflibercept With Adjuvant Micro-Pulsed Yellow Laser Versus Aflibercept Monotherapy in Treatment of Diabetic Macular Edema.
Al Hadi Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年5月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- the number of intravitreal injections
研究概览
简要总结
prospective study evaluating the impact of subthreshold micropulsed laser on the number of Aflibercept injections when used as an adjuvant therapy in eyes with diabetic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years old
- •diagnosed with DME with central macular thickness (CMT) more than 250 µm measured by OCT
- •best corrected visual acuity (BCVA) between 20/400 and 20/40.
排除标准
- •patients with intra-ocular surgery as cataract surgery within 6 months
- •prior intravitreal injection of any drug within the preceding 6 months
- •panretinal photocoagulation (PRP) within the former 4 months.
- •Patients with previous macular laser
- •patients with vitreo-macular traction (VMT) syndrome
- •severe glaucoma
- •other retinal vascular diseases
- •conditions that impede the OCT interpretation
研究组 & 干预措施
Group A
Active Comparator
received aflibercept injections alone
干预措施: Aflibercept Injection (Drug)
Group B
Experimental
received 3 aflibercept injections followed by micropulsed laser
干预措施: Aflibercept Injection (Drug)
Group B
Experimental
received 3 aflibercept injections followed by micropulsed laser
干预措施: micropulsed yellow laser (Other)
结局指标
主要结局
the number of intravitreal injections
时间窗: 18th month follow-up.
the total number of intravitreal aflibercept injections were recorded
Central macular thickness
时间窗: 18 month
in um
次要结局
- best corrected visual acuity measured in ETDRS.(18 months)
研究者
Abeer MohamedSadeck Khattab
associate professor of ophthalmology
Al Hadi Hospital
研究点 (1)
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