Status:
RECRUITING
Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants
Lead Sponsor:
Region Skane
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- ocular infection
- systemic steroid treatment within two weeks before the start of drop treatment
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05387941
Start Date
June 14 2022
End Date
December 1 2028
Last Update
March 12 2024
Active Locations (2)
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1
Skåne University Hospital
Lund, Skåne County, Sweden, 22185
2
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 41685