Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02504944
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : August 31, 2018
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 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.


Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: Propranolol 0.2% eye drops Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Newborn With Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)
Study Start Date : July 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018


Arm Intervention/treatment
Experimental: Propranolol 0.2% eye drops
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.
Drug: Propranolol 0.2% eye drops
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.




Primary Outcome Measures :
  1. Incidence rate of progression from stage 1 ROP to zone II stage 2 ROP with plus [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  2. Incidence rate of progression from stage 1 ROP to zone II stage 3 ROP with plus [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  3. Plasma concentrations of propranolol at the steady state measured by dried blood spots [ Time Frame: 10th day of treatment ]

Secondary Outcome Measures :
  1. Number of newborns who progress to Stage 2 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 3 without plus ROP [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  3. Number of newborns who progress to Stage 4 with total or partial retinal detachment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  4. Number of newborns who progress to Stage 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 ]
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02504944


Locations
Layout table for location information
Italy
Neonatal Intensive Care Unit, Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 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
Neonatal Intensive Care Unit, Azienda Ospedaliera San Gerardo
Monza, Italy
Piermarocchi Stefano
Padova, Italy, 35100
Neonatal Intensive Care Unit, Azienda Ospedaliera Universitaria Senese
Siena, Italy
Neonatal Intensive Care Unit, Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Varese, Italy
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Meyer
Investigators
Layout table for investigator information
Principal Investigator: Luca Filippi, MD A. Meyer University Childrens' Hospital

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Luca Filippi, MD, Azienda Ospedaliero, Universitaria Meyer
ClinicalTrials.gov Identifier: NCT02504944     History of Changes
Other Study ID Numbers: DROP-ROP-0.2%
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
Layout table for MeSH terms
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