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

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 0.2% eye drops (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Azienda Ospedaliero, Universitaria Meyer

Official(s) and/or principal investigator(s):
Luca Filippi, MD, Principal Investigator, Affiliation: A. Meyer University Childrens' Hospital

Overall contact:
Luca Filippi, MD, Phone: +39-055-5662434, Email: l.filippi@meyer.it

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.

Clinical Details

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

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 1 ROP to zone II stage 2 ROP with plus

Incidence rate of progression from stage 1 ROP to zone II stage 3 ROP with plus

Plasma concentrations of propranolol at the steady state measured by dried blood spots

Secondary outcome:

Number of newborns who progress to Stage 2 without plus ROP

Number of newborns who progress to Stage 3 without plus ROP

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

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

Number of newborns who need vitrectomy

Collection of adverse events due to eye drop propranolol treatment

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Preterm newborns (gestational age 23-32 weeks) with stage 1 ROP

- A signed parental informed consent

Exclusion Criteria:

- Newborns with heart failure

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

- Newborns with second or third degree atrioventricular block

- Newborns with congenital cardiovascular anomalies, except for persistent ductus

arteriosus, patent foramen ovale and small ventricular septal defects

- Newborns with hypotension

- Newborns with renal failure

- Newborns with actual cerebral haemorrhage

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

blockers.

- Newborns with a more severe stage of ROP than stage 1

Locations and Contacts

Luca Filippi, MD, Phone: +39-055-5662434, Email: l.filippi@meyer.it

Neonatal Intensive Care Unit, Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy; Recruiting
Salvatore Aversa, MD, Email: aversalvo@hotmail.com
Graziella Iacono, MD, Sub-Investigator
Giuseppe Neascimbeni, MD, Sub-Investigator
Sabina Bettelli, MD, Sub-Investigator

Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital, Florence 50139, Italy; Recruiting
Luca Filippi, MD, Phone: +39-055 5662434, Email: l.filippi@meyer.it
Luca Filippi, MD, Principal Investigator

Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan, Milan 20122, Italy; Recruiting
Giacomo Cavallaro, MD, Email: giacomo.cavallaro@mangiagalli.it
Giacomo Cavallaro, MD, Principal Investigator

Neonatal Intensive Care Unit, Azienda Ospedaliera San Gerardo, Monza, Italy; Recruiting
Valentina Bozzetti, MD, Email: vbozzetti@hotmail.com

Neonatal Intensive Care Unit, Azienda Ospedaliera Universitaria Senese, Siena, Italy; Recruiting
Barbara Tomasini, MD, Email: b.tomasini@ao-siena.toscana.it

Neonatal Intensive Care Unit, Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi, Varese, Italy; Not yet recruiting
Angela Bossi, MD, Email: angela.bossi@ospedale.varese.it

Additional Information

Related publications:

Padrini L, Isacchi B, Bilia AR, Pini A, Lanzi C, Masini E, Della Bona ML, Calvani AM, Ceccantini R, la Marca G, Filippi L. Pharmacokinetics and local safety profile of propranolol eye drops in rabbits. Pediatr Res. 2014 Oct;76(4):378-85. doi: 10.1038/pr.2014.108. Epub 2014 Jul 16.

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: July 2015
Last updated: July 28, 2015

Page last updated: August 23, 2015

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