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
Summary
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 ROPNumber 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
Eligibility
Minimum age: 1 Month.
Maximum age: 4 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Preterm newborns (gestational age 23-32 weeks) with stage 2 ROP, zone II without
plus.
- 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
blockers.
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
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