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

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

Sponsors

Lead sponsor: Azienda Ospedaliero, Universitaria Meyer

Source Azienda Ospedaliero, Universitaria Meyer
Brief Summary

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.

Overall Status Completed
Start Date July 2015
Completion Date August 2018
Primary Completion Date August 2018
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence rate of progression from stage 1 ROP to zone II stage 2 ROP with plus participants will be followed for the duration of hospital stay, an expected average of 2 months
Incidence rate of progression from stage 1 ROP to zone II stage 3 ROP with plus participants will be followed for the duration of hospital stay, an expected average of 2 months
Plasma concentrations of propranolol at the steady state measured by dried blood spots 10th day of treatment
Secondary Outcome
Measure Time Frame
Number of newborns who progress to Stage 2 without plus ROP participants will be followed for the duration of hospital stay, an expected average of 2 months
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
Number of newborns who progress to Stage 4 with total or partial retinal detachment participants will be followed for the duration of hospital stay, an expected average of 2 months
Number of newborns who progress to Stage 5 ROP with total or partial retinal detachment participants will be followed for the duration of hospital stay, an expected average of 2 months
Number of newborns who need vitrectomy participants will be followed for the duration of hospital stay, an expected average of 2 months
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
Enrollment 98
Condition
Intervention

Intervention type: Drug

Intervention name: Propranolol 0.2% eye drops

Description: Enrolled preterm newborns will receive propranolol as ophthalmic solution (0.2%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, four times daily (every 6 hours). Propranolol treatment will be always associated to the conventional approach adopted by the Early Treatment for Retinopathy of Prematurity Study (ETROP) Cooperative Group.

Arm group label: Propranolol 0.2% eye drops

Eligibility

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Luca Filippi, MD Principal Investigator A. Meyer University Childrens' Hospital
Location
facility
Neonatal Intensive Care Unit, Azienda Ospedaliera Spedali Civili di Brescia | Brescia, Italy
Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital | Florence, 50139, Italy
Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan | Milan, 20122, Italy
Neonatal Intensive Care Unit, Azienda Ospedaliera San Gerardo | Monza, Italy
Piermarocchi Stefano | Padova, 35100, Italy
Neonatal Intensive Care Unit, Azienda Ospedaliera Universitaria Senese | Siena, Italy
Neonatal Intensive Care Unit, Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi | Varese, Italy
Location Countries

Italy

Verification Date

August 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Azienda Ospedaliero, Universitaria Meyer

Investigator full name: Luca Filippi

Investigator title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Propranolol 0.2% eye drops

Arm group type: Experimental

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.

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov