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

Bayer0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Bayer
入组人数: 2

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 2 至 11（—）

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

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

发起方

Bayer

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