Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity (PROP-ROP)

Azienda Ospedaliero, Universitaria Meyer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Retinopathy of Prematurity

Treatments: Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01079715

EudraCT Number 2010-018737-21

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 22 to 32 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Propranolol

Experimental group

Description:

Oral Propranolol administration is the experimental arm of this study

Treatment:

Drug: Propranolol

Control

No Intervention group

Description:

Control arm is treated following the standard treatment schedule of Early Treatment For Retinopathy Of Prematurity Cooperative Group