Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants

Launched by REGION SKANE · May 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well dexamethasone eye drops work and their safety for premature infants at risk of a serious eye condition called retinopathy of prematurity (ROP). ROP can cause improper growth of blood vessels in the eye, leading to blindness. The trial aims to understand how these eye drops are absorbed and processed in the body of premature infants, as well as to monitor any potential side effects. The study is open to premature infants born before 30 weeks of gestation who are being screened for ROP at specific hospitals in Sweden.

Infants who qualify will receive the steroid eye drops, which have shown promise in reducing the need for more invasive treatments like injections or laser therapy. During the study, researchers will collect small samples of blood and saliva to learn how the body handles the eye drops. Parents can expect their infants to be closely monitored for any side effects, although the risk is considered low with these eye drops. Additionally, the infants will have their vision checked again when they are 2.5 and 5 years old to see how well they are doing.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • ocular infection
• • systemic steroid treatment within two weeks before the start of drop treatment