Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)

PHASE2CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Retinopathy of Prematurity
Interventions
DRUG

Propranolol 0.2% eye drops

Enrolled preterm newborns will receive propranolol as ophthalmic solution (0.2%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, four times daily (every 6 hours). Propranolol treatment will be always associated to the conventional approach adopted by the Early Treatment for Retinopathy of Prematurity Study (ETROP) Cooperative Group.

Trial Locations (7)

20122

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

35100

Piermarocchi Stefano, Padua

50139

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

Unknown

Neonatal Intensive Care Unit, Azienda Ospedaliera Spedali Civili di Brescia, Brescia

Neonatal Intensive Care Unit, Azienda Ospedaliera San Gerardo, Monza

Neonatal Intensive Care Unit, Azienda Ospedaliera Universitaria Senese, Siena

Neonatal Intensive Care Unit, Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi, Varese

All Listed Sponsors
lead

Meyer Children's Hospital IRCCS

OTHER

NCT02504944 - Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%) | Biotech Hunter | Biotech Hunter