Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age
研究概览
简要总结
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.
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
盲法说明
Open-Label
入排标准
- 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
- •Patients with treatment-naïve retinopathy of prematurity (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)
排除标准
- •Known or suspected chromosomal abnormality, genetic disorder, or syndrome
- •Previous exposure to any Intravitreal (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 neonatal intensive care unit 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 stage 4 and stage 5)
- •ROP involving only Zone III
- •NOTE: Other protocol defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Laser Group
Patients will undergo laser treatment in each eligible eye at baseline.
干预措施: laser photocoagulation (Procedure)
Aflibercept Group
Patients will receive a single intravitreal (IVT) injection per eligible eye at baseline.
干预措施: aflibercept (Drug)
结局指标
主要结局
Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age
时间窗: Baseline to week 52 of chronological age
Active ROP was ROP requiring treatment and unfavorable structural outcome was defined as retinal detachment, macular dragging, macular fold, or retrolental opacity. For participants with both eyes enrolled in the study, both eyes must have met the endpoint. Participants with only one study eye enrolled were responders if the respective eye responded.
次要结局
- Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age(Baseline to to week 52 of chronological age)
- Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(Baseline to Week 52 of chronological age)
- Percentage of Participants With Systematic (Non-ocular) TEAEs and TESAEs(Baseline to Week 52 of chronological age)
- Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age(Baseline to week 52 of chronological age)