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

Information source: Azienda Ospedaliero, Universitaria Meyer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinopathy of Prematurity

Intervention: Propranolol eye drops (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Azienda Ospedaliero, Universitaria Meyer

Official(s) and/or principal investigator(s):
Luca Filippi, MD, Principal Investigator, Affiliation: Azienda Ospedaliero, Universitaria Meyer


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.

Clinical Details

Official title: Safety and Efficacy of Propranolol Eye Drops in Newborns With Retinopathy of Premature (DROP-PROP)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus, stage 4 and stage 5)

Plasma concentrations of propranolol at the steady state

Secondary outcome:

Number of newborns who progress to Stage 3 without plus ROP

Number of newborns who progress to Stage 4 or 5 ROP with total or partial retinal detachment

Number of newborns who need laser treatment

Number of newborns who need rescue treatment with bevacizumab

Number of newborns who need vitrectomy

Collection of adverse events due to eye drop propranolol treatment


Minimum age: 1 Month. Maximum age: 4 Months. Gender(s): Both.


Inclusion Criteria:

- Preterm newborns (gestational age 23-32 weeks) with stage 2 ROP, zone II without


- A signed parental informed consent.

Exclusion Criteria:

- Newborns with heart failure;

- Newborns with congenital cardiovascular anomalies, except for persistent ductus

arteriosus, patent foramen ovale and small ventricular septal defects;

- Newborns with recurrent bradycardia (heart rate < 90 beat per minute);

- Newborns with second or third degree atrioventricular block;

- Newborns with hypotension;

- Newborns with renal failure;

- Newborns with actual cerebral haemorrhage;

- Newborns with other diseases which contraindicate the use of beta-adrenoreceptor


Locations and Contacts

Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital, Florence 50139, Italy

Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan, Milan 20122, Italy

Additional Information

Related publications:

Filippi L, Cavallaro G, Bagnoli P, Dal Monte M, Fiorini P, Donzelli G, Tinelli F, Araimo G, Cristofori G, la Marca G, Della Bona ML, La Torre A, Fortunato P, Furlanetto S, Osnaghi S, Mosca F. Oral propranolol for retinopathy of prematurity: risks, safety concerns, and perspectives. J Pediatr. 2013 Dec;163(6):1570-1577.e6. doi: 10.1016/j.jpeds.2013.07.049. Epub 2013 Sep 18.

Dal Monte M, Casini G, la Marca G, Isacchi B, Filippi L, Bagnoli P. Eye drop propranolol administration promotes the recovery of oxygen-induced retinopathy in mice. Exp Eye Res. 2013 Jun;111:27-35. doi: 10.1016/j.exer.2013.03.013. Epub 2013 Mar 23.

Filippi L, Cavallaro G, Fiorini P, Malvagia S, Della Bona ML, Giocaliere E, Bagnoli P, Dal Monte M, Mosca F, Donzelli G, la Marca G. Propranolol concentrations after oral administration in term and preterm neonates. J Matern Fetal Neonatal Med. 2013 May;26(8):833-40. doi: 10.3109/14767058.2012.755169. Epub 2013 Jan 31.

Della Bona ML, Malvagia S, Villanelli F, Giocaliere E, Ombrone D, Funghini S, Filippi L, Cavallaro G, Bagnoli P, Guerrini R, la Marca G. A rapid liquid chromatography tandem mass spectrometry-based method for measuring propranolol on dried blood spots. J Pharm Biomed Anal. 2013 May 5;78-79:34-8. doi: 10.1016/j.jpba.2013.01.034. Epub 2013 Feb 4.

Starting date: November 2013
Last updated: July 6, 2015

Page last updated: August 23, 2015

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