Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: A Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 3
- 主要终点
- Percentage of participants with absence of active ROP and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment
研究概览
简要总结
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
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, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with less than or equal to 2000 grams of birth weight or less than or equal to 32 weeks of gestational age
- •Bilateral type 1 ROP with one of the following retinal findings in each eye
- •Zone I, stage 1+, 2+, 3+/- disease, or
- •Zone II, stage 2+, 3+, disease, or
排除标准
- •Preterm infants with stage 4 or 5 ROP in one or both eyes
- •Have received any previous surgical or nonsurgical treatment for ROP, including laser photocoagulation, anti-VEGF therapy, vitrectomy
- •Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
- •Have 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 is longer
- •Have active ocular infection within 5 days before or on the day of first investigational treatment
- •Have a history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes
- •Have any contraindication for intravitreal injection clearly stated in the instructions
- •Have any ocular structural abnormality that may affect efficacy assessments
- •Have a history of any other congenital or systemic conditions that are assessed by the investigator to have a significant risk of severe impact on visual function
- •Have any other medical conditions or clinically significant comorbidities or personal circumstances that are assessed by the investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments
研究组 & 干预措施
Conbercept 0.15 mg/0.015mL
intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required
干预措施: Conbercept (Drug)
Conbercept 0.25 mg/0.025mL
intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required
干预措施: Conbercept (Drug)
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 during the observational period after starting study treatment
时间窗: Week 24
To achieve this outcome, participants cannot fulfill any of the following criteria: 1. Require intervention for ROP in either eye at or before the week 24 assessment visit with a treatment modality other than Conbercept 2. Have active ROP in either eye at the week 24 assessment visit 3. Have unfavorable structural outcomes (e.g., retinal detachment, retinal traction, macular abnormalities) in either eye at or before week 24 assessment visit
次要结局
- Percentage of participants with effective single intravitreal injection treatment(Week 24)
- Percentage of participants having reactivation at or before week 24(Week 24)
- Percentage of participants with complete vascularization of the peripheral retina at or before week 24(Week 24)
- Percentage of participants requiring repeated intervention at or before week 24(Week 24)
- Percentage of participants requiring interventions with a second modality for ROP at or before week 24(Week 24)
研究者
Wang Yusheng
Professor
Xijing Hospital