Effect of Pre-operative Adjunctive Anti-VEGF on Growth Factors in Severe Proliferative Diabetic Retinopathy Requiring Surgical Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR
研究概览
简要总结
The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).
详细描述
Traction retinal detachment (TRD) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. Fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the eye. Small, nonrandomized studies have suggested that pre-operative adjunctive anti-VEGF administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Active fibrovascular proliferation due to PDR with TRD given pre-operative clearance for pars plana vitrectomy (PPV) and TRD repair.
排除标准
- •Dense vitreous hemorrhage
- •Inability to follow-up for surgery within 3-7 days after intravitreal injection
- •History of stroke, thromboembolic event, or heart attack within the last 6 months
- •Less than 18 years of age
- •Pregnancy
研究组 & 干预措施
Avastin Injection Group (AIG)
Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
干预措施: Avastin (bevacizumab) (Drug)
Sham Injection Group (SIG)
Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
干预措施: Sham injection (Other)
结局指标
主要结局
The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR
时间窗: 3 months after last surgery
Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.
次要结局
- Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.(3 months after last surgery.)
- Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery.(3 months from last surgery)