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

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ClinicalTrials.gov Identifier: NCT02014454
Recruitment Status : Completed
First Posted : December 18, 2013
Last Update Posted : July 7, 2015
Sponsor:
Information provided by (Responsible Party):
Luca Filippi, 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.


Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: Propranolol eye drops Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Propranolol Eye Drops in Newborns With Retinopathy of Premature (DROP-PROP)
Study Start Date : November 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014


Arm Intervention/treatment
Experimental: Propranolol eye drops

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.

Drug: Propranolol eye drops

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.





Primary Outcome Measures :
  1. Incidence rate of progression from stage 2 ROP to more severe stage ROP (stage 2 or 3 with plus, stage 4 and stage 5) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
    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.

  2. Plasma concentrations of propranolol at the steady state [ Time Frame: 10th day of treatment ]
    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


Secondary Outcome Measures :
  1. Number of newborns who progress to Stage 3 without plus ROP [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  2. Number of newborns who progress to Stage 4 or 5 ROP with total or partial retinal detachment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  3. Number of newborns who need laser treatment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  4. Number of newborns who need rescue treatment with bevacizumab [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  5. Number of newborns who need vitrectomy [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  6. Collection of adverse events due to eye drop propranolol treatment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]


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Ages Eligible for Study:   1 Month to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014454


Locations
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Italy
Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital
Florence, Italy, 50139
Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan
Milan, Italy, 20122
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Meyer
Investigators
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Principal Investigator: Luca Filippi, MD Azienda Ospedaliero, Universitaria Meyer

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Luca Filippi, MD, Azienda Ospedaliero, Universitaria Meyer
ClinicalTrials.gov Identifier: NCT02014454     History of Changes
Other Study ID Numbers: DROP-PROP
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Luca Filippi, Azienda Ospedaliero, Universitaria Meyer:
Retinopathy of prematurity
Propranolol
Eye drops
Newborns
Retinal angiogenesis
Retinal neovascularization

Additional relevant MeSH terms:
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Propranolol
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents