Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity

Phase 2

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Drug: Propranolol

• Registration Number: NCT01079715
• Lead Sponsor: Azienda Ospedaliero, Universitaria Meyer

Brief Summary

The purpose of this study is to determine whether the administration of propranolol is effective in the treatment of the retinopathy of the prematurity.

Detailed Description

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-24
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

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.
   • Hypotension.
   • 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 Informed Consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propranolol	Propranolol	Oral Propranolol administration is the experimental arm of this study

Primary Outcome Measures

Name	Time	Method
The primary aim is to evaluate the safety of propranolol administration	Three months

Secondary Outcome Measures

Name	Time	Method
The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP	six months from the beginning of treatment

Trial Locations

Locations (2)

Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer; 🇮🇹 Florence, Italy

Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy