RAINBOW Extension Study: an Extension Study to Evaluate the Long Term 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
- 180
- 试验地点
- 1
- 主要终点
- Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms
研究概览
简要总结
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)
详细描述
This was a multicenter, open-label extension study where the Visual Acuity (VA) assessment at the child's 5th birthday visit was performed. The study had 2 distinct periods (Epochs). Treatment with study ranibizumab (either as retreatment after ranibizumab had already been injected in the same eye or as switch ranibizumab treatment from study laser therapy administered in the core study) was permitted for eligible eyes with recurrence/worsening of ROP up to and including Week 40 from the baseline visit in the core study (Epoch 1). The remainder of the extension study up to the 5th birthday visit (Epoch 2) was observational, with no study treatment planned to be administered.
In the core study, patients were randomized to 1 of the 3 treatment arms (ranibizumab 0.2 mg, ranibizumab 0.1 mg, and laser). Treatment arm assignment and patient identifier in the extension study remained the same as in the core study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
- •The patient successfully completed the core study H2301, as defined by providing assessments at the Visit 112 (the last scheduled visit in the core study) or, if appropriate, at the last of the additional assessment visits as per protocol in H2301, whichever was latest
- •The patient received study treatment in both eyes at baseline of study H2301
排除标准
- •Patient had a medical condition or personal circumstance which precluded study participation or compliance with study procedures, as assessed by the Investigator
- •Patient had been discontinued from the core study H2301 at any time
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)
结局指标
主要结局
Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms
时间窗: at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit)
The VA assessment at the child's 5th birthday visit was performed using Early Treatment Diabetic Retinopathy Study (ETDRS) methodology. VA measurements were taken in a sitting position at an initial test distance of 3 meters using Lea Symbols charts. Scores represented the number of optotypes (Lea symbols) the participant identified and ranged from 0 to 100, with higher scores indicating better visual acuity. VA was tested in each eye, using the child's current refractive index. The better-seeing eye was defined as the eye with the higher ETDRS score at the 5th birthday visit. If both eyes had the same ETDRS score, then the right eye was assigned as the better-seeing eye.
次要结局
- Number of Participants With Non-ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship (Greater Than or Equal to 3% in Any Arm) by Preferred Term(throughout the study, approximately 5 years)
- Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term(throughout the study, approximately 5 years)
- Refraction Status: Summary of Participants at the Participant's Fifth Birthday Visit(at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit))
- Change From Baseline in Weight(Baseline of the core study, at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) and at the subjects' fifth birthday (maximum 5 years and 4 months post core baseline visit))
- Change From Baseline in Sitting Diastolic Blood Pressure(Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit))
- Change From Baseline in Sitting Systolic Blood Pressure(Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit))
- Number of Participants With the Summary of Respiratory Function Status(at the participants' fifth birthday visit (maximum 5 years and 4 months post core baseline visit))
- Number of Participants With Hearing Impairment of Any Type(at the participants' fifth birthday visit (maximum 5 years and 4 months post core baseline visit))
- Duration of Hospitalization(From baseline of the core study up to 5 years and 4 months post core baseline visit)
- Weight at the Time of First Hospital Discharge(From baseline of the core study up to 5 years and 4 months post core baseline visit)
- Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 40 Weeks Post Core Baseline Visit(at 40 weeks post core baseline visit)
- Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 52 Weeks Post Core Baseline Visit(at 52 weeks post core baseline visit)
- Number of Participants With Absence of All Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit(at or before 40 weeks post baseline visit)
- Visual Acuity (VA) of the Worse-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms(at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit))
- Number of Participants With Absence of All Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit(at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit))
- Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit(at or before 40 weeks post baseline visit)
- Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit(at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit))
- Number of Participants With Absence of All Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit(at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit))
- Number of Participants With Recurrence of ROP up to 52 Weeks Post Baseline Visit in the Core Study(up to 52 weeks post baseline visit in the core study)
- Number of Ranibizumab Injections Received Per Participant Over the Whole Safety Observation Period(up to and including 40 weeks post baseline visit in the core study)
- Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit(at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit))
- Number of Participants With Recurrence of ROP up to 40 Weeks Post Baseline Visit in the Core Study(up to 40 weeks post baseline visit in the core study)
- Refraction Status: Summary of Participants at Participant's 2 Years Corrected Age(at participant's 2 years corrected age (maximum 2 years and 4 months post core baseline visit))
- Change From Baseline in Head Circumference(Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit))