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临床试验/NCT04539106
NCT04539106已完成不适用

Clinical Outcome Following Reinjection of Ranibizumab in Recurrent Cases With Retinopathy of Prematurity

Ameera Gamal Abdelhameed1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2019年6月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
115
试验地点
1
主要终点
full vascularization of the retina

研究概览

简要总结

A retrospective study included reviewing of medical records of preterm babies who were admitted in neonatal intensive care unit (NICU) of Mansoura University children hospital (MUCH) or referred from nearby hospitals for ROP screening during the period from March 2013 to February 2020.

详细描述

Retinopathy of prematurity was diagnosed and classified according to the International Classification of ROP. Data of the patients who received IVR for type 1 ROP or aggressive posterior ROP (AP-ROP) according to early treatment ROP study (ETROP) were collected. Intravitreal ranibizumab injection was performed as follows; topical anesthetic drop was applied, standard aseptic eye preparation with 5% betadine was performed, a lid speculum was inserted and intravitreal injection of 0.25 mg/0.025 ml ranibizumab with a 30-gauge needle 1.5mm from limbus was given. In case of bilateral ROP, both eyes are injected in the same session. Infants were examined a day after the procedure and weekly thereafter until full vascularization of the retina was observed.

ROP reactivation was defined as any of the following: recurrent plus disease, recurrent neovascularization, or reformation of ridge despite treatment . Once recurrence was determined, second injection of IVR (0.25mg/0.025mL) was given to patients or surgery was performed if progressed to stage 4 or 5. All treated infants were examined until complete regression of ROP and full retinal vascularization.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients received IVR for type 1 ROP or aggressive posterior ROP (AP-ROP) according to early treatment ROP study (ETROP) and developed recurrence of ROP

排除标准

  • 未提供

结局指标

主要结局

full vascularization of the retina

时间窗: 6 months

Infants were examined a day after the procedure and weekly thereafter until full vascularization of the retina was observed.

次要结局

未报告次要终点

研究者

发起方
Ameera Gamal Abdelhameed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ameera Gamal Abdelhameed

Lecturer of Ophthalmology

Mansoura University

研究点 (1)

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