Intravitreal Aflibercept Injection With Panretinal Photocoagulation Versus Early Vitrectomy for Diabetic Vitreous Hemorrhage
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Mean best corrected visual acuity(BCVA) change in both groups.
研究概览
简要总结
Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.
详细描述
Selected patients were divided into two groups, Group I for whom intravitreal aflibercept injection followed by panretinal photocoagulation was done and group II for whom early vitrectomy was done.
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
- •Age above 18 years.
- •Type Ι or ΙΙ DM,
- •recent diabetic VH which is causing vision impairment, precluding complete PRP and needing treatment.
- •BCVA is less than 20/70 (log MAR BCVA 0.6) and better than 20/1000 (log MAR BCVA 1.7).
排除标准
- •Tractional retinal detachment.
- •Previous PRP.
- •History of anti VEGF therapy within the past two months.
- •Neovascular glaucoma
- •Subhyaloid hemorrhage.
- •Vitreomacular traction.
- •Diabetic macular edema .
- •Patients with systemic contraindications for anti VEGF or unstable medical conditions as uncontrolled hypertension (persistently above 180/110 mmhg) or recent thromboembolic event within the past six months.
研究组 & 干预措施
Group I
Intravitreal injection of Aflibercept followed by panretinal photocoagulation.
干预措施: Aflibercept Injection [Eylea] (Drug)
Group II: Early vitrectomy.
Early vitrectomy.
干预措施: Vitrectomy (Procedure)
结局指标
主要结局
Mean best corrected visual acuity(BCVA) change in both groups.
时间窗: 9 months follow up.
Final BCVA change measured in log MAR compared to initial BCVA.
次要结局
- Rate of recurrent bleeding.(9 months follow up.)
- Number of additional treatment procedures .(9 months follow up)
研究者
Abeer MohamedSadeck Khattab
Abeer Mohamed Sadeck Khattab ,associate professor of ophthalmology.
Al Hadi Hospital