Retinopathy of Prematurity Clinical Trial
— DROP-PROPOfficial title:
Safety and Efficacy of Propranolol Eye Drops in Newborns With Retinopathy of Premature (DROP-PROP)
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 4 Months |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital | Florence | |
Italy | Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan | Milan |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero, Universitaria Meyer |
Italy,
Dal Monte M, Casini G, la Marca G, Isacchi B, Filippi L, Bagnoli P. Eye drop propranolol administration promotes the recovery of oxygen-induced retinopathy in mice. Exp Eye Res. 2013 Jun;111:27-35. doi: 10.1016/j.exer.2013.03.013. Epub 2013 Mar 23. — View Citation
Della Bona ML, Malvagia S, Villanelli F, Giocaliere E, Ombrone D, Funghini S, Filippi L, Cavallaro G, Bagnoli P, Guerrini R, la Marca G. A rapid liquid chromatography tandem mass spectrometry-based method for measuring propranolol on dried blood spots. J Pharm Biomed Anal. 2013 May 5;78-79:34-8. doi: 10.1016/j.jpba.2013.01.034. Epub 2013 Feb 4. — View Citation
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. — View Citation
Filippi L, Cavallaro G, Fiorini P, Malvagia S, Della Bona ML, Giocaliere E, Bagnoli P, Dal Monte M, Mosca F, Donzelli G, la Marca G. Propranolol concentrations after oral administration in term and preterm neonates. J Matern Fetal Neonatal Med. 2013 May;26(8):833-40. doi: 10.3109/14767058.2012.755169. Epub 2013 Jan 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus, stage 4 and stage 5) | Eye drop propranolol is considered to be effective in counteracting the progression of ROP if the treatment decreases the incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus) from actual 38% to 19% or less. | participants will be followed for the duration of hospital stay, an expected average of 2 months | No |
Primary | Plasma concentrations of propranolol at the steady state | To evaluate the safety of eye drop propranolol we consider the plasma propranolol concentrations at the steady state. In particular it should be always less than 20 ng/ml, which is the plasma concentration, at the steady state, reported after oral administration of propranolol in the PROP-ROP study | 10th day of treatment | Yes |
Secondary | Number of newborns who progress to Stage 3 without plus ROP | participants will be followed for the duration of hospital stay, an expected average of 2 months | No | |
Secondary | Number of newborns who progress to Stage 4 or 5 ROP with total or partial retinal detachment | participants will be followed for the duration of hospital stay, an expected average of 2 months | No | |
Secondary | Number of newborns who need laser treatment | participants will be followed for the duration of hospital stay, an expected average of 2 months | No | |
Secondary | Number of newborns who need rescue treatment with bevacizumab | participants will be followed for the duration of hospital stay, an expected average of 2 months | No | |
Secondary | Number of newborns who need vitrectomy | participants will be followed for the duration of hospital stay, an expected average of 2 months | No | |
Secondary | Collection of adverse events due to eye drop propranolol treatment | participants will be followed for the duration of hospital stay, an expected average of 2 months | Yes |
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