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

Azienda Ospedaliero, Universitaria Meyer

Status and phase: Completed; Phase 2

Conditions: Retinopathy of Prematurity

Treatments: Drug: Propranolol 0.2% eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT02504944

DROP-ROP-0.2%

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

Propranolol 0.2% eye drops

Experimental group

Description:

Enrolled preterm newborns will receive propranolol as ophthalmic solution (0.2%). The treatment will be started as soon as the diagnosis of stage 1 ROP is made and will be continue until the development of retinal vascularization is completed, but no more than 90 days. 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. Propranolol concentrations will be measured on dried blood spots at the steady state (10th day). Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.

Treatment:

Drug: Propranolol 0.2% eye drops