Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Best corrected visual acuity
研究概览
简要总结
Eligible eyes are randomized to two groups. Group A will receive three intravitreal injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of combined bevacizumab and fasudil will be performed with the same frequency.
Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of BCVA and CMT changes.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic patients with diabetic macular edema (DME) and:
- •Central macula thickness> 250μm
- •Visual acuity < 20/40
- •No active proliferative diabetic retinopathy
- •No history of intravitreal anti-VEGF drug injection or macular laser photocoagulation (MPC) within the past 3 months
排除标准
- •History of vitrectomy
- •History of cataract surgery within the past 6 months
- •History of glaucoma or uveitis
- •Presence of any macular disorder other than DME
- •Presence of traction on the macula
- •Significant media opacity
- •Serum creatinine>3mg/ml
研究组 & 干预措施
Intravitreal bevacizumab (Avastin)
Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks
干预措施: Intravitreal injection of bevacizumab (Avastin) (Drug)
Combined intravitreal fasudil and bevacizumab (Avastin)
Dosage: bevacizumab 1.25 mg/0.05 ml + fasudil 0.025mg/0.05ml Frequency: 3 consecutive injections every 4 weeks
干预措施: Intravitreal injection of fasudil and bevacizumab (Avastin) (Drug)
结局指标
主要结局
Best corrected visual acuity
时间窗: 6 months
Snellen E-chart
central macular thickness
时间窗: 6 months
spectral domain optical coherence tomography (SD OCT)
次要结局
- Status of macular perfusion(6 months)
- intraocular inflammation(6 months)
研究者
Zahra Rabbani Khah
Clinical Professor, Ophthalmic Research Center
Shahid Beheshti University of Medical Sciences