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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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 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.