Comparison Between Intravitreal Injection of Ranibizumab and Bevacizumab for Treatment of Type 1 Retinopathy of Prematurity
试验速览
- 阶段
- 3 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- • Regression achieved either by single injection or multiple injections or additional laser therapy at 60 weeks postmenstrual age.
研究概览
简要总结
Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
详细描述
Objectives
To compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
Study population & Sample size Infants with Type 1 ROP (affecting both eyes) screened at neonatal intensive care unit (NICU) of Cairo University.
The sample size is calculated to be 36 eyes of 18 infants using open Epi confidence total 95%, power of the study 80% according to the following : the mean SD of axial length of patients with stage 3 ROP using bevacizumab versus ranibizumab (20.3 1.16 versus 19.4 ).
Study Design
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with a birth weight of ≤ 1500 g or geststional age of ≤ 30 weeks and selected infants with birth weight between 1500 and 2000 g or gestational age of more than 30 weeks with an unstable clinical course, including those requiring cardiorespiratory support. Patients with bilateral disease who will receive bilateral injections, are only included. Type 1 ROP according to ETROP study which is defined as, Zone I ROP with plus disease, Zone I, stage 3 ROP without plus disease and Zone II, stage 2 or 3 ROP with plus disease.
排除标准
- •Eyes with previous intravitreal injections. Eyes with previous laser therapy. Eyes with any other pathology, other than ROP. Eyes with ROP stage 4 or
- •Eyes with mucopurulent or purulent conjunctivitis. Infants who will not be able to comply to the follow-up schedule.
研究组 & 干预措施
Eyes with IVI bevacizumab
0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye
干预措施: Bevacizumab, Ranibizumab (Drug)
Eyes with IVI ranibizumab
A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant
干预措施: Bevacizumab, Ranibizumab (Drug)
结局指标
主要结局
• Regression achieved either by single injection or multiple injections or additional laser therapy at 60 weeks postmenstrual age.
时间窗: 60 weeks PMA
regression of plus disease and the active neovessels
次要结局
- • Recurrence of ROP(60 weeks PMA)
研究者
Ghada Mahmoud Tawfik Ibrahim Eladawy
dr_ghadaeladawy@yahoo.com
Zagazig University