Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature

Safety and Efficacy of Propranolol Eye Drops in Newborns With Retinopathy of Premature (DROP-PROP)

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 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.

Overall Status Completed
Start Date November 2013
Completion Date August 2014
Primary Completion Date August 2014
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus, stage 4 and stage 5) participants will be followed for the duration of hospital stay, an expected average of 2 months
Plasma concentrations of propranolol at the steady state 10th day of treatment
Secondary Outcome
Measure Time Frame
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 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
Number of newborns who need laser treatment participants will be followed for the duration of hospital stay, an expected average of 2 months
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
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 23
Condition
Intervention

Intervention Type: Drug

Intervention Name: Propranolol eye drops

Description: All 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.

Arm Group Label: Propranolol eye drops

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 1 Month

Maximum Age: 4 Months

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Luca Filippi, MD Principal Investigator Azienda Ospedaliero, Universitaria Meyer
Location
Facility:
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
Location Countries

Italy

Verification Date

July 2015

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

Label: Propranolol eye drops

Type: Experimental

Description: All 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.

Acronym DROP-PROP
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov