Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity (RoProp)

  • End date
    Nov 25, 2024
  • participants needed
  • sponsor
    University of Zurich
Updated on 25 October 2022


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.


Threshold Retinopathy of Prematurity (ROP), observed in a fraction of extremely premature infants, is characterized by retinal vessel proliferation that threatens vision secondary to retinal detachment. Currently available treatments (ablative laser surgery or intravitreal anti-VEGF injections) may prevent most but not all cases of permanent ROP-mediated blindness and are associated with significant costs and side effects.

Orally administered propranolol, a commonly used drug to treat hypertension, may be effective in halting progression of ROP to severe stages, as suggested by preliminary data from small studies. Propranolol has been used for decades not only in adult patients but also in newborn infants with heart diseases. Moreover, it has been licensed in 2014 for the use in newborn infants with hemangioma in the European Union, Switzerland and the United States. This multicenter randomized placebo-controlled trial aims to assess whether oral propranolol given to extremely premature infants below 28 weeks gestational age reduces the rates of threshold ROP.

Condition Retinopathy of Prematurity
Treatment Placebo, Propranolol
Clinical Study IdentifierNCT03083431
SponsorUniversity of Zurich
Last Modified on25 October 2022


Yes No Not Sure

Inclusion Criteria

Preterm infant born before 28 weeks gestation
Birth weight below 1250 g
weeks of age (at randomisation)
Postmenstrual age 31 0/7 - 36 6/7 weeks
Ophthalmoscopic evidence of incipient ROP (stage 1 or 2, with or without plus disease in any zone)
Written informed consent by parents or legal guardian, according to national requirements

Exclusion Criteria

Patients will be screened for the presence of exclusion criteria in a two-step process: (1)
once all inclusion criteria have met, and (2) once informed consent has been obtained
st screening
ROP stage 3, AP-ROP or suspected AP-ROP (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
PHACE syndrome (posterior fossa anomalies, large infantile hemangiomas of the
face, neck, and/or scalp, arterial lesions, cardiac abnormalities/coarctation of
the aorta, eye anomalies) (risk of cerebrovascular complications)
Very large hemangioma (risk of hyperkalemia), as judged by the attending
Medication of the infant with rifampicin or phenobarbitone (enhanced metabolic
Chronic kidney impairment (serum creatinine > 1.3 mg/dl [115 μmol/L])
Severe liver dysfunction (ALT (GPT) > 900 U/L)
Known hypersensitivity to propranolol or any of the excipients (see 6.3.1.)
Prinzmetal's angina, Raynaud's phenomenon (severe peripheral arterial circulatory
disturbance), or pheochromocytoma (contraindications for propranolol in adults
not occurring in newborn infants)
Any circumstances that make the investigator believe that participation in the
study leads to exceptional medical or organisational problems for the patient
Inclusion may be postponed in the presence of the following acute and transient
Acute severe infection
Arterial hypotension requiring therapeutic intervention by local standards
Heart rate consistently (> 1h) < 100/min
Concurrent treatment with insulin (risk of hypoglycaemia)
Discontinuation of enteral feeding
Persistent hypoglycaemia (blood glucose < 36 mg/dl [2.0 mmol/L] in 3 consecutive
samples immediately preceding enrolment)
Persistent hyperkalemia (venous serum potassium > 5.9 mmol/L in 3 consecutive
samples immediately preceding enrolment)
Persistent neutropenia (absolute neutrophil counts <1,000/μL in 3 consecutive
samples immediately preceding enrolment)
nd screening (re-screening)
Conditions that prohibit propranolol therapy such as: Atrio-ventricular block
grade 2 or 3 hypertrophic cardiomyopathy, sinoatrial block, uncontrolled heart
failure or cardiogenic shock, bronchial asthma
Medication of the infant or the mother if breastfeeding with clonidine
reserpine, angiotensin-converting enzyme inhibitors, angiotensin-receptor
antagonists (contraindicated in preterm infants) or antiarrhythmic drugs
including amiodarone, propafenone, lidocaine, digoxin/digitoxin, quinidine
verapamil, diltiazem, bepridil (pharmacodynamic interaction)
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