NCT05387941

Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants

Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants With Retinopathy of Prematurity- a Feasibility Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 30 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
DRUG	Dexamethasone Ophthalmic	one drop daily in each eye with retinopathy of prematurity of a predefined stage.

Timeline

• Start date: 2022-06-14
• Primary completion: 2025-06-01
• Completion: 2028-12-01
• First posted: 2022-05-24
• Last updated: 2024-03-12

Locations

2 sites across 1 country: Sweden