Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature

Phase 2CompletedNCT02014454

Meyer Children's Hospital IRCCS23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinopathy of Prematurity

Interventions

All the enrolled preterm newborns will receive propranolol as ophthalmic solution (0,1%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, three times daily (every 8 hours).The treatment will continue until the complete development of retinal vascularisation, but no more than 60 days. The propranolol treatment will be always associated to the conventional approach adopted by the ETROP Cooperative Group.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 4 Months

Medical Language ↔ Plain English

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 (2)

Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital

Florence, Italy

Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan

Milan, Italy

Outcomes

Primary Outcomes

Incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus, stage 4 and stage 5)

Eye drop propranolol is considered to be effective in counteracting the progression of ROP if the treatment decreases the incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus) from actual 38% to 19% or less.