Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants With Retinopathy of Prematurity- a Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Pharmacokinetics: half-life of plasma concentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
研究概览
简要总结
Background and study aims
When an infant is born premature, the blood vessels in the eyes have not developed fully on the retina, and can start to grow incorrectly and result in blindness. To prevent this from happening, premature infants are often screened, and treated with laser or injections into the eye to prevent retinal detachment. A new treatment strategy with steroid eye drops have been found to prevent serious blood vessel growth. The treatment is commonly used in older children and adults to treat different inflammatory conditions, but how the drop is absorbed in premature infants and if there is any risk of side-effects is poorly investigated. The aim of this study is to document how the steroid drop is absorbed and excreted in premature infants and to study if there is a risk of any side effects.
Who can participate?
Premature infants born before gestational age week 30, that undergo eye-screening at Sahlgrenska University Hospital in Gothenburg and Skånes University Hospital in Malmö and Lund or at Helsingborg Hospital, in the need for steroid eye-drop treatment against pathological vessels. It is not possible to participate if the infant has received systemic steroid treatment 2 weeks prior to the eye-drop treatment, or has an ongoing ocular infection.
What does the study involve?
The study involves blood and saliva samples according to a specific protocol designed to be able to learn about the uptake and breakdown of the steroid in premature infants. Measurements of blood pressure, growth and a few urine samples will also be collected during the treatment period usually lasting for some weeks.
At 2.5 and 5 years of age, visual acuity, refractive errors and retinal thickness measurements will be noted.
What are the possible benefits and risks of participating?
The infant will receive steroid eye-drops that have been noted to heavily reduce the number of infants that develop retinal changes that require injections or laser treatment.
The blood samples have been reduced to an absolute minimum in volume and numbers, but will entail some extra samplings from the infant.
The infant will be rigorously checked with regard to any possible side effects from the steroid treatment. Possible but unlikely side effects from the low dose in eye drops are; elevated blood pressure, retarded growth, lowered endogenous steroid production during the eye-drop treatment, increase in blood glucose, and an increase in intra-ocular pressure.
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 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants screened for retinopathy of prematurity (ROP) at Sahlgrenska University Hospital in Gothenburg, at Skåne University Hospital in Malmö and Lund and at Helsingborg Hospital.
- •zone I stage 1 or 2 ROP without plus disease, posterior zone II stage 2 ROP without plus disease, or zone II stage 3 ROP without plus disease. ROP needs to be documented by digital widefield photography and classification confirmed by two ophthalmologist.
排除标准
- •ocular infection
- •systemic steroid treatment within two weeks before the start of drop treatment
研究组 & 干预措施
Dexamethasone treated infants
15 infants that receive dexamethasone eye drops for treatment of retinopathy of prematurity will be included, and both serum and saliva samples will be collected in order to find out the pharmacokinetic properties of dexamethasone in eye drops according to a pre-specified sampling scheme specifically designed for this purpose by experts in pediatric pharmacokinetics.
干预措施: Dexamethasone Ophthalmic (Drug)
结局指标
主要结局
Pharmacokinetics: half-life of plasma concentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
时间窗: up to 14 weeks
Half-life of dexamethasone- t½, hours
Pharmacokinetics: maximum plasma concentration of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
时间窗: up to 14 weeks
Maximum plasma concentration- Cmax, nmol/L
Pharmacokinetics: saliva koncentrations of dexamethasone during treatment with dexamethasone eye drops.
时间窗: up to 14 weeks
Half-life of dexamethasone- t½, hours
Pharmacokinetics: area under the concentration-time curve for saliva dexamethasone from time point 0 to time t of the last measured concentration above the limit of quantification time.
时间窗: up to 14 weeks
AUC0-t, nmol.h/L
Pharmacokinetics: area under the concentration-time curve for saliva dexamethasone from time point 0 to infinity;
时间窗: up to 14 weeks
AUC0-∞, nmol.h/L
Pharmacokinetics: apparent volume of distribution
时间窗: up to 14 weeks
Vz/F, L
Safety: serum concentrations of endogenous corticosteroids before, during and after treatment with dexamethasone eye drops measured with mass spectrometry.
时间窗: up to 14 weeks
Endogenous levels of corticosteroids, nmol/L
Safety: saliva concentrations of endogenous corticosteroids before, during and after treatment with dexamethasone eye drops.
时间窗: up to 14 weeks
Endogenous levels of corticosteroids, nmol/L
Pharmacokinetics: saliva koncentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
时间窗: up to 14 weeks
Maximum saliva concentration- Cmax, nmol/L
Pharmacokinetics: time to reach maximum plasma concentration of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
时间窗: up to 14 weeks
tmax, hours
Pharmacokinetics: time to reach maximum saliva concentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
时间窗: up to 14 weeks
tmax, hours
Pharmacokinetics: area under the concentration-time curve for plasma dexamethasone from time point 0 to time t of the last measured concentration above the limit of quantification time.
时间窗: up to 14 weeks
AUC0-t, nmol.h/L
Pharmacokinetics: area under the concentration-time curve for plasma dexamethasone from time point 0 to infinity;
时间窗: up to 14 weeks
AUC0-∞, nmol.h/L
Pharmacokinetics: apparent total body clearance
时间窗: up to 14 weeks
CL/F, L/h
次要结局
- To describe if dexamethasone eye drops delay the intervention for type 1 ROP in cases without regression by calculating the time from detection of type 2 ROP to type 1 ROP(Up to 14 weeks)
- To describe if dexamethasone eye drop treatment before intervention for type 1 ROP reduces the number of recurrences after the intervention.(Up to 14 weeks)
- To find out if retinal morphology measured with optical coherence tomography is affected by dexamethasone eye drops at 2.5 years of age.(after 2.5 years)
- To find out if dexamethasone eye drops affect refractive errors at 2.5 years of age(after 2.5 years)
- To find out if dexamethasone eye drops affect visual acuity at 5 years of age(after 5 years)
- To find out if dexamethasone eye drops affect refractive errors at 5 years of age(after 5 years)
- To find out if retinal morphology measured with optical coherence tomography is affected by dexamethasone eye drops at 5 years of age.(after 5 years)
- To find out if dexamethasone eye drops affect visual acuity at 2.5 years of age(after 2.5 years)