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Completed

NCT Number: NCT02014454

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

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.

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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

Age range

1 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital, Florence, 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 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.

Treatment and study plan

Propranolol eye drops

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

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

Acronym: DROP-PROP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 18, 2013
Registry last updated
Jul 7, 2015

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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