A Single-Center Trial of Intravitreous Injections of Macugen (Pegaptanib Sodium) Given at Least 7 Days Before Vitrectomy Secondary To Tractional Retinal Detachment in Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention.
研究概览
简要总结
Primary objective of this trial will be to evaluate the safety and efficacy of intravitreal injections of Macugen (pegaptanib sodium) when given at least 7-14 days prior to vitrectomy in subjects with tractional retinal detachment (with or withoutmacular involvement) secondary to proliferative diabetic retinopathy.
Secondary objective is to evaluate regression of neovascularization and progression of macular traction utilizing OCT and fundus photographs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either gender aged 75 years or below diagnosed with tractional retinal detachment secondary to proliferative diabetic retinopathy.
排除标准
- •Subjects with vitreous hemorrhage obscuring the posterior pole will be excluded.
研究组 & 干预措施
Macugen (Pegaptanib Sodium)
Open-label, single-center trial. Subjects will recieve intravitreous injections of Macugen 7-14 days before Vitrectomy.
干预措施: Macugen (Pegaptanib Sodium) (Drug)
结局指标
主要结局
Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention.
时间窗: 7-14 days prior to surgical intervention
次要结局
- Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs(7-14 days prior to surgical intervention)