Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
The aim of the present study is to evaluate the safety and efficacy of propranolol eye drops
in preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm
newborns (gestational age 23-32 weeks) with a stage 2 ROP (zone II without plus) will receive
propranolol eye drops treatment until retinal vascularization will be completed.
Propranolol concentrations will be measured on dried blood spots during the first 3 days of
treatment and at the steady state. Cardiovascular and respiratory parameters will be
continuously monitored. Blood samplings checking metabolic, renal and liver functions will be
performed periodically, as well as cardiac function, in order to verify the treatment safety.
Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment,
the ROP progression and the possible complications.