NCT03083431 Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 276 participants in total. It began in 2022-09-22 with a primary completion date of 2028-12-31.

Brief Summary

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

Inclusion criteria: * 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 * 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: * 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 * 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 physician * Medication of the infant with rifampicin or phenobarbitone (enhanced metabolic clearance) * 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 organizational problems for the patient * 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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