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Prevention study for Retinopathy of Prematurity
Official title Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
ClinicalTrials.gov ID: NCT03083431
What this study is testing
What is Propranolol?
Propranolol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for retinopathy of prematurity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 15
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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...
- Very large hemangioma (risk of hyperkalemia), as judged by the attending physician
See the full eligibility 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Baden-Wurttemberg, Germany
- Zurich, Canton of Zurich, Switzerland
- Ankara, Ankara, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 weeks to 15 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Baden-Wurttemberg, Germany; Zurich, Canton of Zurich, Switzerland; Ankara, Ankara, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.