Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-15
SponsorUniversity of Zurich

About this trial

Extremely premature infants are at risk of developing a potentially blinding eye disease, called retinopathy of prematurity (ROP). Currently available treatment, consisting of laser surgery or injection of drugs into the eye balls, may prevent most but not all cases of permanent ROP-mediated blindness. Both types of treatment are associated with significant costs and side effects.

An orally administered drug commonly used to treat hypertension, propranolol, may be effective in halting progression of ROP to severe stages, as suggested by preliminary data from small studies. As severe (threshold) ROP is an overall rare disease, the effectiveness of propranolol in combating ROP can only be assessed in a large, multicenter randomized controlled trial involving hospitals caring for extremely preterm infants of diverse origin.

Eligibility criteria

Qualifiers

Preterm infant born before 28 week's gestation

Birth weight below 1250 g

At least 5 weeks of age (at randomisation)

PMA 310/7 - 36 6/7 weeks

Disqualifiers

ROP stage ≥ 3, AP-ROP or suspected AP-ROP, or any other ROP requiring an intervention (study endpoint already reached).

Conditions that indicate open label propranolol such as: thyrotoxicosis, arterial hypertension or certain heart diseases (such as tetralogy of Fallot, paroxysmal supraventricular tachycardia, or long QT syndrome) etc.

Major congenital malformations or known chromosomal anomalies

Colobomas and other eye malformations

Trial design

Treatments tested in this trial

  • Propranolol
  • Placebo

Treatment groups

276 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Zurich

Lead sponsor

Ankara University

Collaborator

University Hospital Tuebingen

Collaborator