Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity
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 (Drug)
Phase: Phase 2/Phase 3
Sponsored by: Azienda Ospedaliero, Universitaria Meyer
Official(s) and/or principal investigator(s):
Luca Filippi, M.D., Principal Investigator, Affiliation: Azienda Ospedaliero-Universitaria A. Meyer, Firenze, Italy
The purpose of this study is to determine whether the administration of propranolol is
effective in the treatment of the retinopathy of the prematurity.
Official title: Safety and Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity: a Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: The primary aim is to evaluate the safety of propranolol administration
Secondary outcome: The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP
Retinopathy of Prematurity (ROP) is still a major cause of blindness in children in
developed countries around the world, and an increasing cause of blindness in developing
countries. The ablation of the retina with photocoagulation by laser or cryotherapy reduces
the incidence of blindness by suppressing the neovascular phase of ROP. However, the visual
outcomes after treatment are often poor. The development of ROP depends largely from
vascular endothelial growth factor (VEGF). The reduction of VEGF expression in the
neovascular phase might prevent destructive neovascularization in ROP.
The purpose of this study is to evaluate whether the administration of propranolol is safe
and is able to reduce the incidence of blindness by suppressing the neovascular phase of ROP
compared to a control group receiving conventional laser therapy.
Minimum age: 22 Weeks.
Maximum age: 32 Weeks.
1. Infants who have been screened for ROP (≤ 32 weeks gestation) who develop Stage 2 ROP
in zone II without plus.
2. Informed Consent from a parent
1. Newborns with one or more of the following conditions at the enrollment in the study:
- Heart failure.
- Recurrent episodes of bradycardia (Heart rate less than 90 bpm).
- Atrio-ventricular block (second or third degree).
- Significant congenital heart anomaly, not including patent ductus arteriosus,
patent foramen ovale or small ventricular septal defect.
- Renal failure.
- Cerebral hemorrhage.
- Other diseases which contraindicate the use of beta-blockers
2. Newborns with ROP stages more advances than Stage 2 in zone II without plus.
3. Informed Consent from a parent refused. This will mean that an infant automatically
will receive standard laser therapy. No data will be used from an infant without
Locations and Contacts
Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer, Florence I-50139, Italy
Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan I-20122, Italy
Filippi L, Cavallaro G, Fiorini P, Daniotti M, Benedetti V, Cristofori G, Araimo G, Ramenghi L, La Torre A, Fortunato P, Pollazzi L, la Marca G, Malvagia S, Bagnoli P, Ristori C, Dal Monte M, Bilia AR, Isacchi B, Furlanetto S, Tinelli F, Cioni G, Donzelli G, Osnaghi S, Mosca F. Study protocol: safety and efficacy of propranolol in newborns with Retinopathy of Prematurity (PROP-ROP): ISRCTN18523491. BMC Pediatr. 2010 Nov 18;10:83. doi: 10.1186/1471-2431-10-83.
Starting date: January 2010
Last updated: November 24, 2012