A Dosing Study of Two Different Doses (0.3125mg Versus 0.625mg) Intravitreal Bevacizumab for Type 1 ROP (Retinopathy of Prematurity)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment.
研究概览
简要总结
The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding :
Serum Systemic VEGF levels. Retinal Vascularization.
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
- 年龄范围
- 28 Weeks 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with Type 1 ROP according to ETROP study which is defined as:
- •Zone I ROP with plus disease
- •Zone I, stage 3 ROP without plus disease
- •Zone II, stage 2 or 3 ROP with plus disease
排除标准
- •Eyes with previous intravitreal injection
- •Eyes with previous laser therapy
- •Eyes with any other intraocular pathology other than ROP (congenital cataract, congenital glaucoma, any retinal pathology other than ROP)
研究组 & 干预措施
Group A recieved 0.3125mg intravitreal bevacizumab in both eyes
9 infants in group A with type 1 ROP , received 0.3125mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection .
干预措施: Intravitreal Bevacizumab (Drug)
Group B received 0.625mg intravitreal bevacizumab in both eyes
10 infants in group B with type 1 ROP , received 0.625mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection .
干预措施: Intravitreal Bevacizumab (Drug)
结局指标
主要结局
The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment.
时间窗: "up to 60 weeks postmenstrual age"
Rescue therapy is defined as the need of a second dose of 0.625 mg bevacizumab reinjection or laser at any time during follow up period.
Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups.
时间窗: at day 0 (baseline ) , 1 week and 4 weeks post-injection
serum systemic VEGF measured using human VEGF ELISA kit
次要结局
- Occurrence of any adverse events from intravitreal-injection(Within 4 weeks from intravitreal injection)
研究者
Nooran Mohammed Abdelhameed Abdelkader
Assistant lecturer ophthalmology department Cairo university
Cairo University