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Study protocol: safety and efficacy of propranolol 0.2% eye drops in newborns with a precocious stage of retinopathy of prematurity (DROP-ROP-0.2%): a multicenter, open-label, single arm, phase II trial.

Neonatal Intensive Care Unit - Medical Surgical Fetal-Neonatal Department, Meyer University Children's' Hospital, viale Pieraccini 24, 50134, Florence, Italy. l.filippi@meyer.it. Neonatal Intensive Care Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy. Neonatal Intensive Care Unit - Medical Surgical Fetal-Neonatal Department, Meyer University Children's' Hospital, viale Pieraccini 24, 50134, Florence, Italy. Neonatal Intensive Care Unit, MBBM Foundation, San Gerardo Hospital, Monza, Italy. Department of Pediatrics, Obstetrics and Reproductive Medicine, Neonatal Intensive Care Unit, University Hospital of Siena, Policlinico Santa Maria alle Scotte, Siena, Italy. Department of Molecular and Developmental Medicine, University of Siena, Via Banchi di Sotto, 55, 53100, Siena, Italy. Neonatal Intensive Care Unit, Del Ponte Hospital, Varese, Italy. Neonatal Intensive Care Unit, Children's Hospital, University Hospital "Spedali Civili" of Brescia, Brescia, Italy. Pediatric Ophthalmology, A. Meyer" University Children's Hospital, Florence, Italy. Department of Ophthalmology, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy. Department of Ophthalomolgy, ASST Monza, San Gerardo Hospital, Monza, Italy. Pediatric Ophthalmology, University Hospital of Siena, Policlinico Santa Maria alle Scotte, Siena, Italy. Department of Surgical and Morphological Sciences, Section of Ophthalmology, University of Insubria, Varese, Italy. Department of Ophthalmology, University Hospital "Spedali Civili" of Brescia, Brescia, Italy. Department of Neurosciences, Psychology, Pharmacology and Child Health, University of Florence, Newborn Screening, Biochemistry and Pharmacology Laboratory, Meyer Children's University Hospital, Florence, Italy. Laboratory "G.A. Maccacro", Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy. Department of Biology, Unit of General Physiology, University of Pisa, Pisa, Italy. Department of Pharmacy, "A. Meyer" University Children's Hospital, Florence, Italy. Clinical Trial Office, "A. Meyer" University Children's Hospital, viale Pieraccini 24, 50134, Florence, Italy. Department of Pediatrics, Maastricht University Medical Center (MUMC+), School for Oncology and Developmental Biology (GROW), Maastricht, The Netherlands.

BMC pediatrics. 2017;(1):165
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Abstract

BACKGROUND 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, 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). METHODS A 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. DISCUSSION Propranolol 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 REGISTRATION ClinicalTrials.gov Identifier NCT02504944, registered on July 19, 2015, updated July 12, 2016. EudraCT Number 2014-005472-29.

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Publication Type : Clinical Trial ; Multicenter Study

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