NCT04004208已完成3 期
Open-label, Randomized, Two-Arm, Controlled Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal (IVT) Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity (ROP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 113
- 试验地点
- 64
- 主要终点
- Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes
研究概览
简要总结
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.
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
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g
- •Subjects with treatment-naïve ROP classified according to the International Classification for ROP in at least one eye as:
- •Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or
- •Zone II Stage 2 plus or 3 plus, or
- •Aggressive posterior retinopathy of prematurity (AP-ROP)
- •Weight at baseline (day of treatment) ≥ 800 g
- •Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Known or suspected chromosomal abnormality, genetic disorder or syndrome
- •Previous exposure to any IVT or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding
- •Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure)
- •Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a NICU specialist and a study ophthalmologist
- •Presence of active ocular infection within 5 days of the first treatment
- •Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5)
- •ROP involving only Zone III
- •Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint
- •Postnatal treatment with oral or intravenous corticosteroids at an equivalent dose of prednisone ≥ 1 mg/kg/day for > 2 weeks within 14 days of the first study intervention
- •Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy)
- •Participation of the subject or the mother in other clinical trials requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening, or within 30 days or 5 half-lives of administration of the previous study drug, whichever is longer
研究组 & 干预措施
Aflibercept arm
Experimental
Subjects randomized to aflibercept will receive a intravitreal (IVT) injection of Dose A aflibercept per eligible eye at baseline and, if needed, up to a defined number of additional injections in each eye.
干预措施: Eylea (Aflibercept, BAY86-5321) (Drug)
Laser photocoagulation arm
Active Comparator
Subjects randomized to laser photocoagulation will receive treatment in each eligible eye at baseline. Retreatments may be administered if needed.
干预措施: Laser photocoagulation (Procedure)
结局指标
主要结局
Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes
时间窗: At 24 weeks after starting study treatment
Active ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity.
次要结局
- Proportion of Participants Requiring Intervention With a Second Treatment Modality(From baseline (treatment) up to week 24.)
- Proportion of Participants With Recurrence of ROP(From baseline (treatment) up to week 24.)
- Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium(From baseline (treatment) up to week 24.)
- Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs)(From baseline (treatment) up to week 24)
- Percentage of Participants With Ocular Serious Adverse Events (SAEs)(From baseline (treatment) up to week 24)
- Percentage of Participants With Systemic TEAEs(From baseline (treatment) up to week 24)
- Percentage of Participants With Systemic SAEs(From baseline (treatment) up to week 24)
- Concentrations of Free Aflibercept in Plasma(From Day 1 up to week 24.)
- Number of Participants With Anti-drug Antibodies (ADA)(Baseline (treatment) and 12 weeks after aflibercept injection)
- Number of Participants With Potential Neutralizing Antibodies (NAb)(At 12 weeks after aflibercept injection)
- Number of Aflibercept Administrations(From baseline (treatment) up to week 24.)
- Number of Laser Treatments(From baseline (treatment) up to week 24.)
研究者
研究点 (64)
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