EUCTR2018-002611-99-HU进行中（未招募）1 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) - FIREFLeYe
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Gestational age at birth = 32 weeks or birth weight = 1500 g
- •Type of Participant and Disease Characteristics
- •2.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 AP-ROP
- •3.Weight at baseline (day of treatment) = 800 g
- •4.Male or female
- •5.Signed informed consent from parent(s)/legally authorized representative(s) as described in Section 10.1.3 of the clinical trial protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical trial protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 135
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are excluded from the study if any of the following per subject” criteria are met. A potential study eye is excluded from the study if any of the per eye” criteria are met:
- •Medical Conditions – per subject
- •1.Known or suspected chromosomal abnormality, genetic disorder or syndrome
- •2.Previous exposure to any IVT or systemic anti-VEGF agent, including maternal exposure during pregnancy and/or during breastfeeding
- •3.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)
- •4.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
- •5.Presence of active ocular infection within 5 days of the first treatment
- •Medical Conditions – per eye
- •6.Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5)
- •7.ROP involving only Zone III
- •8.Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint Prior/Concomitant Therapy – per subject
- •9.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
- •Prior/Concomitant Therapy – per eye
- •10.Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy) Prior/Concurrent Clinical Study Experience
- •11.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
研究者
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