Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- measuring the main change in visual acuity
研究概览
简要总结
Diabetic macular edema (DME) is a sign of diabetic retinopathy that affects central vision. It is also a leading cause of visual decline in younger patients, especially in developing countries like our Arab community. Intra-vitrreal injection of anti-vascular endothelial growth factor (AVEGF) in management of DME had significant improvement in the final logMAR Un-corrected Distant Visual Acuity ( UCDVA) and logMAR Best Corrected Distant Visual Acuity (BCDVA), as well as reduction in the central retinal thickness from baseline measurement.
详细描述
The investigators randomly assigned four hundreds eyes of diabetic patients with central diabetic macular edema for intra-vitreal injection of AVEGF group I (200 patients eyes) received aflibercept 2.0 mg and group II (200 patients eyes) received ranibizumab 0.3 mg. Injection was at 4 weeks interval according to the used protocol. The primary outcome was measuring the mean change in visual acuity as functional outcome and the secondary outcomes were the mean change in central macular thickness, as anatomical outcome rather than safety and efficacy of those two anti-VEGF drugs.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 or 2 diabetes mellitus with central DME clinically as well as documented by optical coherence tomography (OCT) imaging
- •The age of the patients at least 20 years old
- •Patients not receiving AVEGF injection, at least for one year
- •The BCDVA letter score of at least one eye (range, 0 to 115, with higher scores indicating better visual acuity of 90 (Snellen = 20/32) to 40 (Snellen = 20/320) and central DME .
排除标准
- •Patients with cataract
- •Glaucoma patient
- •Previous AVEGF injection in less than one year
- •Patients not attending all of the scheduled follow up visits
研究组 & 干预措施
AFLIBERCEPT
Intra-vitreal injection of AFLIBERCEPT
干预措施: Aflibercept (Drug)
RANIBIZUMAB
Intra-vitreal injection of RANIBIZUMAB
干预措施: Ranibizumab (Drug)
结局指标
主要结局
measuring the main change in visual acuity
时间窗: 2 years
measuring the main change in visual acuity in logarithm of the minimum angle of resolution (log MAR) using projector chart as functional outcome
次要结局
- the main change in central macular thickness(2 years)
研究者
Shaaban Elwan
Assistant professor of ophthalmology
Minia University