Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
Status:
Withdrawn
Trial end date:
2023-11-03
Target enrollment:
Participant gender:
Summary
Extremely premature infants are at risk of developing a potentially blinding eye disease,
called retinopathy of prematurity (ROP). Currently available treatment, consisting of laser
surgery or injection of drugs into the eye balls, may prevent most but not all cases of
permanent ROP-mediated blindness. Both types of treatment are associated with significant
costs and side effects. An orally administered drug commonly used to treat hypertension,
propranolol, may be effective in halting progression of ROP to severe stages, as suggested by
preliminary data from two small studies. Propranolol has been used for decades not only in
adult patients but also in newborn infants with heart diseases. Moreover, it has been
licensed in 2014 for the use in newborn infants with hemangiomas in the European Union,
Switzerland and the United States. As severe (threshold) ROP is an overall rare disease, the
effectiveness of propranolol in combating ROP can only be assessed in a large, multicenter
randomized controlled trial involving hospitals caring for extremely preterm infants of
diverse origin.
Phase:
Phase 2
Details
Lead Sponsor:
Charite University, Berlin, Germany
Collaborators:
Ankara University Hadassah Medical Organization University Hospital, Zürich