NCT03453281已完成4 期
Central Macular Thickness, Macular Electroretinogram, and Visual Acuity in Patients With Diabetic Macular Edema After Intravitreal Aflibercept Injection. A One Month Pre-Post Intervention Follow Up Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Central macular thickness
研究概览
简要总结
This is a one month pre post intervention study. Subjects with diabetic macular edema were given intravitreal anti VEGF (Aflibercept) injection. Central retinal thickness, macular electrophysiology, and visual acuity were observed one week and one month after injection was given to the eye to describe early anatomical, physiological, and clinical changes. We hypothesized that changes to these outcomes can be found and documented.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age of 18 y.o.
- •Diagnosed with Type 1 or 2 Diabetes Mellitus
- •Have either one of mild non-proliferative diabetic retinopathy (NPDR), moderate NPDR, severe NPDR, or Proliferative Diabetic Retinopathy with clinically significant macular edema according to Early Treatment for Diabetic Retinopathy Study (ETDRS) criteria
- •Best corrected visual acuity between one meter finger counting to 6/12 (ETDRS chart)
- •Minimum Central Macular Thickness by Optical Coherence Tomography examination of 250 um
- •Willing to participate and sign the informed consent.
排除标准
- •Ongoing pregnancy or planning to be pregnant for the next 6 months.
- •Media opacity (e.g. corneal scar, corneal edema, cataract, vitreous hemorrhage) which make macular OCT not possible
- •History of intraocular surgery in the last 6 months
- •Vitreoretinal surface disorders e.g. epiretinal membrane, vitreoretinal traction
- •History of panretinal laser photocoagulation in the last 6 months
- •Presence of iris neovascularization
- •History of eye trauma
- •HbA1c level > 10,0 %
- •Any other contraindication(s) for intravitreal anti VEGF injection.
研究组 & 干预措施
Aflibercept Injection [Eylea]
Experimental
Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes
干预措施: Aflibercept Injection [Eylea] (Drug)
结局指标
主要结局
Central macular thickness
时间窗: One month after intravitreal Aflibercept injection
Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany \[in µm\]
次要结局
- Central macular thickness(One week after intravitreal Aflibercept injection)
- Amplitude of P1 wave(One month after intravitreal Aflibercept injection)
- Amplitude of N1 wave(One month after intravitreal Aflibercept injection)
- Amplitude of N2 wave(One month after intravitreal Aflibercept injection)
- Implisit time of P1 wave(One month after intravitreal Aflibercept injection)
- Implisit time of N1 wave(One month after intravitreal Aflibercept injection)
- Implisit time of N2 wave(One month after intravitreal Aflibercept injection)
- Best corrected visual acuity(One month after intravitreal Aflibercept injection)
- Uncorrected visual acuity(One month after intravitreal Aflibercept injection)
- Best corrected visual acuity (number of letters)(One month after intravitreal Aflibercept injection)
- Uncorrected visual acuity (number of letters)(One month after intravitreal Aflibercept injection)
研究者
Martin Hertanto
Resident, Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia
Indonesia University
研究点 (1)
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