Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 19
- 主要终点
- To demonstrate non-inferiority of Anti-VEGF treatment to standard-of-care laser
研究概览
简要总结
The purpose of this study is to determine whether a single intravitreal (into the gel of the eye) injection of Avastin 0.625mg or 0.75mg is equivalent (non-inferior) to treatment with standard of care laser in infants with Type I pre-threshold retinopathy of prematurity (ROP) diagnosed at 30-36 weeks gestational age.
详细描述
Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries.
The retina lines the inside of the eye. It functions as "film" within the camera, which is the eye. When an infant is born prematurely, the vascular network necessary to nourish the retina has not fully developed. As a consequence, in some infants abnormal vessels grow instead of the normal ones--a condition known as ROP. The abnormal vessels carry scar tissue along with them, and may lead to retinal detachment and blindness if the eye is not treated.
The multi-center trial of Cryotherapy for Retinopathy of Prematurity (CRYo-ROP) Study demonstrated that ablation of the peripheral avascular retina reduced the risk of poor structural and visual outcome due to retinal distortion or detachment in ROP (1980's). The ablated retina is not functional and is not amendable to regeneration.
Peripheral retinal ablation is not universally effective in fostering regression of ROP. This is particularly true for an aggressive form of ROP (aggressive posterior ROP, or APROP), which typically afflicts profoundly premature and sick neonates. In this subset of infants, progression of ROP to retinal detachments in both eyes and even blindness may occur despite timely and complete peripheral retinal laser ablation.
RATIONALE:
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
- 30 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn babies at participating NICU's who meet inclusion criteria
- •Outborn babies transferred to participating NICU's who meet inclusion criteria
- •Type 1 pre-threshold ROP
- •No prior treatment
- •Post menstrual age less than 36 1/7 weeks
- •Post menstrual age greater than 30 weeks
排除标准
- •Fatal systemic anomaly
- •An ocular anomaly of one or both eye affecting the retina or choroid
- •An ocular anomaly precluding use of the RetCam (ex., microphthalmia)
- •Neonatologist feels inclusion will unduly challenge the infant
- •Refusal of initial consent
- •Refusal of subsequent evaluation
- •Media opacity precluding fundus visualization (ex., cataract)
- •Any ocular or periocular infection(s)
研究组 & 干预措施
Bevacizumab (Avastin) 0.75mg/0.03cc
1/3 of study participants will be randomized to this treatment in one eye (study eye) and the other eye will receive laser (fellow eye)
干预措施: Bevacizumab (Drug)
Bevacizumab (Avastin) 0.625mg/0.025cc
1/3 of patients will be randomized to this treatment in 1 eye (study eye) and the other eye will receive laser (fellow eye).
干预措施: Bevacizumab (Drug)
Laser ablation
1/3 of study participants will be randomized to this treatment in both eyes (study eye and fellow eye)
干预措施: Bevacizumab (Drug)
结局指标
主要结局
To demonstrate non-inferiority of Anti-VEGF treatment to standard-of-care laser
时间窗: With patient #58, 116 and 174 (within 3 months after each patient being enrolled)
It is the intent of this clinical study to develop alternative therapy (a single bevacizumab injection) to standard therapy (laser ablation) and to show that bevacizumab is as safe and efficacious as laser.
次要结局
- Decreased laser ablation and improved vascular maturity(With patient #58, 116 & 174 (within 3 months after each patient being enrolled))
研究者
Michael T. Trese, M.D.
VitreoRetinal Surgeon & Researcher
Vision Research Foundation