Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 11
- 主要终点
- Number of Participants With Successful Treatment of ROP
研究概览
简要总结
The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than currently used for severe retinopathy of prematurity (ROP), is effective in this study, and can be tested in future larger studies.
详细描述
Despite promising initial results using empirical doses of bevacizumab based on half the adult dose for treatment of acute severe ROP, little is known about lower doses of bevacizumab for ROP. An increasing number of ophthalmologists are treating premature infants with severe ROP using bevacizumab. Given the potential systemic and ocular adverse effects of intravitreal bevacizumab injections, determining a lower effective dose of bevacizumab is an important next step. The proposed study will test progressively lower doses to find a dose to take forward to a future larger study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 ROP; defined as:
- •Zone I, any stage ROP with plus disease, or
- •Zone I, stage 3 ROP without plus disease, or
- •Zone II, stage 2 or 3 ROP with plus disease
- •No previous treatment for ROP in the study eye; no previous bevacizumab treatment in the non-study eye
排除标准
- •The following exclusions apply to the study eye:
- •Nasolacrimal duct obstruction
- •Major ocular anomalies (e.g., cataract, coloboma)
- •Any opacity that precludes an adequate view of the retina
- •If purulent ocular discharge is present in either eye, then the infant is ineligible.
研究组 & 干预措施
Bevacizumab 0.250 mg
Dosage of injected Bevacizumab to be studied
干预措施: Bevacizumab (Drug)
Bevacizumab 0.125 mg
Dosage of injected Bevacizumab to be studied
干预措施: Bevacizumab (Drug)
Bevacizumab 0.063 mg
Dosage of injected Bevacizumab to be studied
干预措施: Bevacizumab (Drug)
Bevacizumab 0.031 mg
Dosage of injected Bevacizumab to be studied
干预措施: Bevacizumab (Drug)
Bevacizumab 0.016 mg
Dosage of injected Bevacizumab to be studied
干预措施: Bevacizumab (Drug)
Bevacizumab 0.008 mg
Dosage of injected Bevacizumab to be studied
干预措施: Bevacizumab (Drug)
Bevacizumab 0.004 mg
Dosage of injected Bevacizumab to be studied
干预措施: Bevacizumab (Drug)
Bevacizumab 0.002 mg
Dosage of injected Bevacizumab to be studied
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Number of Participants With Successful Treatment of ROP
时间窗: 4 weeks post-injection
Success is defined as improvement\* by the 4-day exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. \* For infants with plus disease, improvement by the 4-day post-injection exam is defined as plus disease no longer being present. For infants with type 1 ROP without plus disease (i.e., zone I, stage 3), improvement by the 4-day post-injection exam is defined as: (1) a significant reduction in severity and/or extent of extraretinal neovascularization, and, (2) if pre-plus was present pre-injection, reduction in the degree of abnormal vascular dilation and/or tortuosity. A dose will be considered effective if it successfully treats at least 80% of subjects.
次要结局
- Visual Fixation Status at 12 Months(12-month corrected age)
- Distribution of VEGF Levels(4 weeks post-injection)
- Number of Study Eyes Requiring Additional Treatment/s for ROP(12-month corrected age)
- Any Adverse Events or Complications Since the 4-week Exam(12-month corrected age)
- Distribution of Avastin Levels(4 weeks post-injection)
- Proportion of Infants for Whom at Least One Event Was Reported(Enrollment to 12-month corrected age)
- Proportion of Infants With an Adverse Event Thought by Investigator to be Related to Study Drug(Enrollment to 12-month corrected age)
- Count of Infants for Whom at Least One Serious Adverse Event Was Reported(Enrollment to 12-month corrected age)
- Number of Infant Deaths(Enrollment to 12-month corrected age)
- Number of Infants With 24-Month Extended Follow Up Exam(24-month corrected age)
- Number of Fellow Eyes Requiring Additional Treatment/s for ROP(12-month corrected age)