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NCT Number: NCT02504944

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

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Diseases Retinal Neovascularization

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neonatal Intensive Care Unit, Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propranolol 0.2% eye drops

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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