Safety and Efficacy of Propranolol Eye Drops in Newborns With Retinopathy of Premature (DROP-PROP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus, stage 4 and stage 5)
研究概览
简要总结
The aim of the present study is to evaluate the safety and efficacy of propranolol eye drops in preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 2 ROP (zone II without plus) will receive propranolol eye drops treatment until retinal vascularization will be completed.
Propranolol concentrations will be measured on dried blood spots during the first 3 days of treatment and at the steady state. Cardiovascular and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.
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
- 1 Month 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm newborns (gestational age 23-32 weeks) with stage 2 ROP, zone II without plus.
- •A signed parental informed consent.
排除标准
- •Newborns with heart failure;
- •Newborns with congenital cardiovascular anomalies, except for persistent ductus arteriosus, patent foramen ovale and small ventricular septal defects;
- •Newborns with recurrent bradycardia (heart rate < 90 beat per minute);
- •Newborns with second or third degree atrioventricular block;
- •Newborns with hypotension;
- •Newborns with renal failure;
- •Newborns with actual cerebral haemorrhage;
- •Newborns with other diseases which contraindicate the use of beta-adrenoreceptor blockers.
研究组 & 干预措施
Propranolol eye drops
All the enrolled preterm newborns will receive propranolol as ophthalmic solution (0,1%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, three times daily (every 8 hours).The treatment will continue until the complete development of retinal vascularization, but no more than 60 days.
The propranolol treatment will be always associated to the conventional approach adopted by the Early Treatment for Retinopathy of Prematurity Study (ETROP Cooperative Group.
干预措施: Propranolol eye drops (Drug)
结局指标
主要结局
Incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus, stage 4 and stage 5)
时间窗: participants will be followed for the duration of hospital stay, an expected average of 2 months
Eye drop propranolol is considered to be effective in counteracting the progression of ROP if the treatment decreases the incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus) from actual 38% to 19% or less.
Plasma concentrations of propranolol at the steady state
时间窗: 10th day of treatment
To evaluate the safety of eye drop propranolol we consider the plasma propranolol concentrations at the steady state. In particular it should be always less than 20 ng/ml, which is the plasma concentration, at the steady state, reported after oral administration of propranolol in the PROP-ROP study
次要结局
- Number of newborns who progress to Stage 4 or 5 ROP with total or partial retinal detachment(participants will be followed for the duration of hospital stay, an expected average of 2 months)
- Collection of adverse events due to eye drop propranolol treatment(participants will be followed for the duration of hospital stay, an expected average of 2 months)
- Number of newborns who progress to Stage 3 without plus ROP(participants will be followed for the duration of hospital stay, an expected average of 2 months)
- Number of newborns who need vitrectomy(participants will be followed for the duration of hospital stay, an expected average of 2 months)
- Number of newborns who need laser treatment(participants will be followed for the duration of hospital stay, an expected average of 2 months)
- Number of newborns who need rescue treatment with bevacizumab(participants will be followed for the duration of hospital stay, an expected average of 2 months)
研究者
Luca Filippi
MD
Azienda Ospedaliero, Universitaria Meyer