Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
ConditionRetinopathy 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Propranolol
DrugOral propranolol (1.6 mg propranolol-hydrochloride/kg/d in 4 divided dosages)
Placebo
DrugOral solution containing the same excipients as propranolol solution
Treatment groups
276 Participants
are divided into 2 treatment groupsGroup A: PropranololExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Survival without adverse ophthalmological outcome (stage ≥ 3, AP-ROP, or any ROP treatment)
The primary endpoint for efficacy is survival until 48 weeks postmenstrual age without adverse ophthalmological outcome (stage ≥ 3, AP-ROP, or any ROP treatment) diagnosed according to the International Committee for the Classification of Retinopathy of Prematurity Revisited.
Time frame
48 weeks postmenstrual ageSecondary outcomes
1
Time to adverse ophthalmological outcome in days
Time to adverse ophthalmological outcome in days (alternative to primary endpoint to account for the timing, considering death as a competing risk)
Time frame
48 weeks postmenstrual age2
Survival without adverse ophthalmological outcome
Survival without adverse ophthalmological outcome (as defined for the primary outcome)
Time frame
48 weeks postmenstrual age3
Survival with adverse ophthalmological outcome
Survival with adverse ophthalmological outcome (as defined for the primary outcome)
Time frame
48 weeks postmenstrual age4
Survival without local treatment for ROP
Survival without local treatment for ROP (ablative laser surgery or intravitreal injections of anti-VEGF agents).
Time frame
48 weeks postmenstrual ageOther outcomes
1
Intraventricular haemorrhages (all grades)
Intraventricular haemorrhage (all grades)
Time frame
48 weeks postmenstrual age2
Posthaemorrhagic hydrocephalus requiring intervention
Posthaemorrhagic hydrocephalus requiring intervention
Time frame
48 weeks postmenstrual age3
Cystic leukomalacia
Cystic leukomalacia
Time frame
48 weeks postmenstrual age4
Persistent ductus arteriosus requiring treatment
Persistent ductus arteriosus requiring treatment
Time frame
48 weeks postmenstrual ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Zurich
Lead sponsor
Ankara University
Collaborator
University Hospital Tuebingen
Collaborator
Source ClinicalTrials.gov