Abstract
BackgroundRetinopathy of prematurity (ROP) still represents one of the leading causes of visual impairment in childhood. Systemic propranolol has proven to be effective in reducing ROP progression in preterm newborns, although safety was not sufficiently guaranteed. On the contrary, topical treatment with propranolol eye micro-drops at a concentration of 0.1% had an optimal safety profile in preterm newborns with ROP, but was not sufficiently effective in reducing the disease progression if administered at an advanced stage (during stage 2). The aim of the present protocol is to evaluate the safety and efficacy of propranolol 0.2% eye micro-drops in preterm newborns at a more precocious stage of ROP (stage 1).MethodsA multicenter, open-label, phase II, clinical trial, planned according to the Simon optimal two-stage design, will be performed to analyze the safety and efficacy of propranolol 0.2% eye micro-drops in preterm newborns with stage 1 ROP. Preterm newborns with a gestational age of 23–32 weeks, with a stage 1 ROP will receive propranolol 0.2% eye micro-drops treatment until retinal vascularization has been completed, but for no longer than 90 days. Hemodynamic and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions, as well as electrocardiogram and echocardiogram, will be periodically performed to investigate treatment safety. Additionally, propranolol plasma levels will be measured at the steady state, on the 10th day of treatment. To assess the efficacy of topical treatment, the ROP progression from stage 1 ROP to stage 2 or 3 with plus will be evaluated by serial ophthalmologic examinations.DiscussionPropranolol eye micro-drops could represent an ideal strategy in counteracting ROP, because it is definitely safer than oral administration, inexpensive and an easily affordable treatment. Establishing the optimal dosage and treatment schedule is to date a crucial issue.Trial registrationClinicalTrials.gov Identifier NCT02504944, registered on July 19, 2015, updated July 12, 2016. EudraCT Number 2014–005472-29.
Highlights
Retinopathy of prematurity (ROP) still represents one of the leading causes of visual impairment in childhood
The aim of the present study is to evaluate the therapeutic role of propranolol 0.2% eye micro-drops in newborns with a precocious stage of ROP
Treatment with oral propranolol is effective in preventing ROP progression in preterm newborns, but appears unsafe
Summary
Retinopathy of prematurity (ROP) still represents one of the leading causes of visual impairment in childhood. Systemic propranolol has proven to be effective in reducing ROP progression in preterm newborns, safety was not sufficiently guaranteed. Topical treatment with propranolol eye micro-drops at a concentration of 0.1% had an optimal safety profile in preterm newborns with ROP, but was not sufficiently effective in reducing the disease progression if administered at an advanced stage (during stage 2). Background and rationale Retinopathy of prematurity (ROP) is a potentially blinding disease caused by pathologic angiogenesis that occurs in the incompletely vascularized retina of preterm newborns. ROP still represents a leading cause of potentially avoidable visual impairment and blindness in childhood. Prematurity and low birth weight are the main factors associated with ROP, other factors (i.e. respiratory failure, fetal hemorrhage, intra-ventricular hemorrhage, blood transfusions, hyperglycemia, sepsis, necrotizing enterocolitis) have been described as contributing factors to ROP development [8, 9]
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