Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye
drops in treating preterm newborns with a precocious stage of retinopathy of prematurity
(ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 1 ROP will receive
propranolol 0.2% eye drops treatment until retinal vascularization will be completed, but no
more than 90 days.
Propranolol concentrations will be measured on dried blood spots at the steady state (10th
day). 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.