Evaluation of Efficacy & Outcomes of Intra-vitreal Ranibizumab Injection in the Treatment of Aggressive Posterior Retinopathy of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Disease regression following intravitreal ranibizumab
研究概览
简要总结
Aggressive posterior retinopathy of prematurity (AP-ROP) is a severe form of retinopathy of prematurity that can progress rapidly and lead to retinal detachment and permanent vision loss if not treated promptly. Although laser photocoagulation has traditionally been the standard treatment, intravitreal anti-vascular endothelial growth factor (anti-VEGF) medications such as ranibizumab have emerged as an alternative treatment because they may preserve the developing peripheral retina.
This study was designed to evaluate the effectiveness and safety of intravitreal ranibizumab in premature infants with AP-ROP. The study assessed the initial response to treatment, the frequency and timing of disease reactivation, the need for additional injections, retinal vascularization during follow-up, and treatment-related complications.
The information obtained from this study is intended to improve understanding of the role of ranibizumab in the management of AP-ROP and to guide follow-up strategies for infants receiving anti-VEGF therapy.
详细描述
**Detailed Description**
Aggressive posterior retinopathy of prematurity (AP-ROP) is a rapidly progressive and vision-threatening subtype of retinopathy of prematurity (ROP) characterized by prominent plus disease, posterior retinal involvement, and rapid progression to retinal detachment if left untreated. Although laser photocoagulation has long been considered the standard treatment for severe ROP, its application in AP-ROP may be technically challenging because of the posterior location of the disease and is associated with permanent ablation of the peripheral retina, high myopia, and visual field constriction.
Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has emerged as an alternative treatment that promotes rapid regression of retinal neovascularization while preserving peripheral retinal tissue. Ranibizumab is characterized by a shorter systemic and intravitreal half-life than other anti-VEGF agents, which may reduce systemic VEGF suppression but may also be associated with a higher risk of disease reactivation, necessitating prolonged surveillance after treatment.
This prospective interventional study was designed to evaluate the efficacy and safety of intravitreal ranibizumab as primary treatment for AP-ROP. The study aimed to assess the rate and timing of disease regression and reactivation, the need for additional intravitreal injections, retinal vascularization during follow-up, and anatomical outcomes. The study also sought to characterize the morphological patterns of disease reactivation and evaluate treatment-related ocular and systemic complications.
The findings are intended to contribute to the growing body of evidence regarding anti-VEGF therapy for AP-ROP and to provide additional data on long-term disease behavior following ranibizumab treatment in premature infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants diagnosed with aggressive posterior retinopathy of prematurity (AP-ROP) according to the International Classification of Retinopathy of Prematurity.
- •Gestational age ≤34 weeks or birth weight ≤2000 g.
- •Infants with gestational age >34 weeks or birth weight >2000 g were eligible if they had additional systemic risk factors, including respiratory distress syndrome, patent ductus arteriosus, sepsis, necrotizing enterocolitis, need for mechanical ventilation, or blood transfusion.
- •Infants whose parents or legal guardians provided written informed consent for treatment and follow-up.
排除标准
- •Previous treatment for retinopathy of prematurity with intravitreal anti-VEGF therapy, laser photocoagulation, cryotherapy, or vitreoretinal surgery.
- •Presence of retinal disease other than retinopathy of prematurity.
- •Major congenital ocular anomalies that could interfere with retinal assessment or treatment response.
- •Known genetic syndromes or systemic conditions judged by the investigators to significantly affect retinal vascular development or study follow-up.
- •Media opacity or other ocular condition preventing adequate fundus examination or retinal imaging.
- •Inability to complete the planned follow-up schedule.
- •Refusal or withdrawal of consent by parents or legal guardians.
结局指标
主要结局
Disease regression following intravitreal ranibizumab
时间窗: 1 week after the initial intravitreal ranibizumab injection
Proportion of eyes demonstrating regression of aggressive posterior retinopathy of prematurity (AP-ROP), defined by disease resolution or involution in the form of resolution of plus disease, reduction in vascular tortuosity and dilation, regression of extraretinal neovascularization, and continued peripheral retinal vascularization.
次要结局
- Complete retinal Vascularization(up to 72 weeks postmenstrual age)
- Disease Reactivation(From the initial injection until completion of follow-up (up to 72 weeks postmenstrual age).)
- Time to first reactivation(Up to 72 weeks postmenstrual age.)
- Number of intravitreal ranibizumab injections(Up to 72 weeks postmenstrual age.)
- Treatment-related complications(From treatment until completion of follow-up (up to 72 weeks postmenstrual age).)
研究者
Ahmed Mansour , MD, PhD
Lecturer
Ain Shams University