RAINBOW Study: a Randomized, Controlled Study Evaluating the Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24
研究概览
简要总结
The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).
详细描述
The study consisted of a screening period (screening and randomization could occur up to 3 days before the administration of the first investigational treatment), followed by a treatment and follow-up period (Day 1 to Day 169).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants with a birth weight of less than 1500 g
- •bilateral ROP with one of the following retinal findings in each eye: Zone I, stage 1+, 2+, 3 or 3+ disease, or Zone II, stage 3+ disease, or Aggressive posterior retinopathy of prematurity (AP-ROP)
排除标准
- •ROP disease characteristic in either eye other than that listed above at the time of the first investigational treatment
- •A history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes
- •Had received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
- •Had been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
- •Had used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever was longer
- •Had ocular structural abnormalities that were assessed by the Investigator to have had a clinically significant impact on study assessments
- •Had active ocular infection within 5 days before or on the day of first investigational treatment
- •Had a history of hydrocephalus requiring treatment
- •Had a history of any other neurological conditions that are assessed by the Investigator to have a significant risk of severe impact on visual function
- •Had any other medical conditions or clinically significant comorbidities or personal circumstances that were assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments (e.g., poor life expectancy, pupil not able to be adequately dilated, unable to comply with the visit schedule)
研究组 & 干预措施
Ranibizumab 0.2 mg
1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
干预措施: Ranibizumab (Drug)
Ranibizumab 0.1 mg
1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
干预措施: Ranibizumab (Drug)
Laser therapy
Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
干预措施: Laser therapy (Procedure)
结局指标
主要结局
Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24
时间窗: Week 24
To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates.
次要结局
- Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24(Week 24)
- Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit(Day 1 (after initiation of study treatment) up to study exit (Day 169))
- Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24(Week 24)
- Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24(Week 24)
- Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29(Day 1 (Baseline), Day 15 and Day 29)
- Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29(Day 1 (Baseline), Day 15 and Day 29)
- Total Number of Ranibizumab Injections Received at Week 24(Week 24)
- Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24(Week 24)
- Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169(Baseline, Day 85, Day 169)
- Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169(Baseline, Day 85, Day 169)
- Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169(Baseline, Day 85, Day 169)