Retinopathy of Prematurity | Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature
Retinopathy of Prematurity research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Retinopathy of Prematurity
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Propranolol eye dropsAll 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 vascularisation, but no more than 60 days. The propranolol treatment will be always associated to the conventional approach adopted by the ETROP Cooperative Group.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Propranolol eye dropsAll 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.
Start Date: November 2013
Completed Date: August 2014
Phase: Phase 2
Primary Outcome: Incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus, stage 4 and stage 5)
Secondary Outcome: Number of newborns who progress to Stage 3 without plus ROP
Study sponsors, principal investigator, and references
Principal Investigator: Luca Filippi, MD
Lead Sponsor: Azienda Ospedaliero, Universitaria Meyer
Filippi L, Cavallaro G, Bagnoli P, Dal Monte M, Fiorini P, Donzelli G, Tinelli F, Araimo G, Cristofori G, la Marca G, Della Bona ML, La Torre A, Fortunato P, Furlanetto S, Osnaghi S, Mosca F. Oral propranolol for retinopathy of prematurity: risks, safety concerns, and perspectives. J Pediatr. 2013 Dec;163(6):1570-1577.e6. doi: 10.1016/j.jpeds.2013.07.049. Epub 2013 Sep 18.