Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature

PHASE2CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Retinopathy of Prematurity
Interventions
DRUG

Propranolol eye drops

"All the enrolled preterm newborns will receive propranolol as ophthalmic solution (0,1%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, three times daily (every 8 hours).The treatment will continue until the complete development of retinal vascularisation, but no more than 60 days.~The propranolol treatment will be always associated to the conventional approach adopted by the ETROP Cooperative Group."

Trial Locations (2)

20122

Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan, Milan

50139

Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital, Florence

All Listed Sponsors
lead

Meyer Children's Hospital IRCCS

OTHER

NCT02014454 - Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature | Biotech Hunter | Biotech Hunter