Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye drops in treating preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 1 ROP will receive propranolol 0.2% eye drops treatment until retinal vascularization will be completed, but no more than 90 days.

Propranolol concentrations will be measured on dried blood spots at the steady state (10th day). 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero, Universitaria Meyer
• Treatments: Ophthalmic Solutions; Propranolol; Tetrahydrozoline

Criteria

Inclusion Criteria:

• Preterm newborns (gestational age 23-32 weeks) with stage 1 ROP

• A signed parental informed consent

Exclusion Criteria:

• Newborns with heart failure

• Newborns with recurrent bradycardia (heart rate < 90 beat per minute)

• Newborns with second or third degree atrioventricular block

• Newborns with congenital cardiovascular anomalies, except for persistent ductus arteriosus, patent foramen ovale and small ventricular septal defects

• Newborns with hypotension

• Newborns with renal failure

• Newborns with actual cerebral haemorrhage

• Newborns with other diseases which contraindicate the use of beta-adrenoreceptor blockers.

• Newborns with a more severe stage of ROP than stage 1