Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature (DROP-PROP)

Azienda Ospedaliero, Universitaria Meyer

Status and phase: Completed; Phase 2

Conditions: Retinopathy of Prematurity

Treatments: Drug: Propranolol eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT02014454

DROP-PROP

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 1 to 4 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Propranolol eye drops

Experimental group

Description:

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 vascularization, but no more than 60 days. The propranolol treatment will be always associated to the conventional approach adopted by the Early Treatment for Retinopathy of Prematurity Study (ETROP Cooperative Group.

Treatment:

Drug: Propranolol eye drops