Clinical Trial: Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety and Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity: a Pilot Study

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 Summary:

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.

Sponsor: Azienda Ospedaliero, Universitaria Meyer

Current Primary Outcome: The primary aim is to evaluate the safety of propranolol administration [ Time Frame: Three months ]

Original Primary Outcome: The primary aim is to evaluate the safety of propranolol administration [ Time Frame: Weekly ]

Current Secondary Outcome: The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP [ Time Frame: six months from the beginning of treatment ]

Original Secondary Outcome: The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP [ Time Frame: monthly from the beginning of treatment ]

Information By: Azienda Ospedaliero, Universitaria Meyer

Dates:
Date Received: March 2, 2010
Date Started: January 2010
Date Completion:
Last Updated: November 24, 2012
Last Verified: November 2012