Retinopathy of PrematurityPhase 2RoPropNCT03083431
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
A Phase 2 study testing Propranolol in people with Retinopathy of Prematurity, run by University of Zurich at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Sep 2022to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076
Axel R Franz, Prof.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Christoph M Rüegger, +41432539810, christoph.rueegger@usz.ch
Claudia Knoepfli, claudia.knoepfli@usz.ch
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University School of Medicine Children's Hospital
Ankara, Ankara, 06590
Ömer Erdeve, Prof.
About this study
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.
Read the detailed description
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.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Propranolol, Placebo
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Oral propranolol (1.6 mg propranolol-hydrochloride/kg/d in 4 divided dosages)
PlaceboDrug
Oral solution containing the same excipients as propranolol solution
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | Oral propranolol (1.6 mg propranolol-HCl/kg/d in 3-4 divided dosages) given for a maximum of 10 weeks (depending on postmenstrual gestational age at birth) Receives: Drug: Propranolol |
| Placebo | Placebo comparator | Placebo (same duration as oral propranolol solution) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks postmenstrual age
Secondary outcomes (8)
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)
Measured: 48 weeks postmenstrual age
Survival without adverse ophthalmological outcome
Survival without adverse ophthalmological outcome (as defined for the primary outcome)
Measured: 48 weeks postmenstrual age
Survival with adverse ophthalmological outcome
Survival with adverse ophthalmological outcome (as defined for the primary outcome)
Measured: 48 weeks postmenstrual age
Survival without local treatment for ROP
Survival without local treatment for ROP (ablative laser surgery or intravitreal injections of anti-VEGF agents).
Measured: 48 weeks postmenstrual age
Death until discharge
Death until discharge
Measured: 48 weeks postmenstrual age
Death until 48 weeks postmenstrual age
Death until 48 weeks postmenstrual age
Measured: 48 weeks postmenstrual age
Recurrence of ROP in infants treated with anti-VEGF-antagonists
Recurrence of ROP in infants treated with anti-VEGF-antagonists
Measured: 70 (+/- 2 weeks) postmenstrual age
Need for repeated ROP therapy in infants treated with anti-VEGF-antagonists
Need for repeated ROP therapy in infants treated with anti-VEGF-antagonists
Measured: 70 (+/- 2 weeks) postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start22 Sep 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University, University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Dirk Bassler, M.D., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083431
- Sponsor's protocol ID
- RoProp
- Other IDs
- 32ER30_173677, 2017-002124-24, 2017
- Acronym
- RoProp
- Status last verified
- May 2026
- First submitted
- 13 Mar 2017
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data set containing gestational age (only weeks), birth weight (in 100g categories), year of birth, country, gender, intervention (propranolol or placebo), outcome (retinopathy of prematurity, maximum stage), date and type of treatment for retinopathy if any
Publications
Buhrer C, Bassler D. Oral Propranolol: A New Treatment for Infants with Retinopathy of Prematurity? Neonatology. 2015;108(1):49-52. doi: 10.1159/000381659. Epub 2015 May 9.
PubMed 25968340Buhrer C, Erdeve O, Bassler D, Bar-Oz B. Oral propranolol for prevention of threshold retinopathy of prematurity (ROPROP): protocol of a randomised controlled trial. BMJ Open. 2018 Jul 6;8(7):e021749. doi: 10.1136/bmjopen-2018-021749.
PubMed 29982217
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT03083431
- Acronym / sponsor ID
- RoProp / RoProp
- Conditions
- Retinopathy of Prematurity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Ankara University, University Hospital Tuebingen
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: PropranololOral propranolol (1.6 mg propranolol-HCl/kg/d in 3-4 divided dosages) given for a maximum of 10 weeks (depending on postmenstrual gestational age at birth) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (same duration as oral propranolol solution) |
Who may qualify
- Ages
- 5 to 15 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololOral propranolol (1.6 mg propranolol-hydrochloride/kg/d in 4 divided dosages) | Drug | Propranolol |
| PlaceboOral solution containing the same excipients as propranolol solution | Drug | Placebo |
Primary outcome
Survival without adverse ophthalmological outcome (stage ≥ 3, AP-ROP, or any ROP treatment)
Time frame: 48 weeks postmenstrual age
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.
8 secondary outcomes
Time to adverse ophthalmological outcome in days
Time frame: 48 weeks postmenstrual age
Survival without adverse ophthalmological outcome
Time frame: 48 weeks postmenstrual age
Survival with adverse ophthalmological outcome
Time frame: 48 weeks postmenstrual age
Survival without local treatment for ROP
Time frame: 48 weeks postmenstrual age
Death until discharge
Time frame: 48 weeks postmenstrual age
Death until 48 weeks postmenstrual age
Time frame: 48 weeks postmenstrual age
Recurrence of ROP in infants treated with anti-VEGF-antagonists
Time frame: 70 (+/- 2 weeks) postmenstrual age
Need for repeated ROP therapy in infants treated with anti-VEGF-antagonists
Time frame: 70 (+/- 2 weeks) postmenstrual age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 25968340Buhrer C, Bassler D. Oral Propranolol: A New Treatment for Infants with Retinopathy of Prematurity? Neonatology. 2015;108(1):49-52. doi: 10.1159/000381659. Epub 2015 May 9.
- Results publication: PubMed 29982217Buhrer C, Erdeve O, Bassler D, Bar-Oz B. Oral propranolol for prevention of threshold retinopathy of prematurity (ROPROP): protocol of a randomised controlled trial. BMJ Open. 2018 Jul 6;8(7):e021749. doi: 10.1136/bmjopen-2018-021749.
- Individual participant dataSharing planned: Yes. Anonymized data set containing gestational age (only weeks), birth weight (in 100g categories), year of birth, country, gender, intervention (propranolol or placebo), outcome (retinopathy of prematurity, maximum stage), date and type of treatment for retinopathy if any
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dirk Bassler, M.D. principal investigator
University of Zurich
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol in people with Retinopathy of Prematurity, run by University of Zurich at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Switzerland, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dirk Bassler, M.D. (+41 44 255 53 40, dirk.bassler@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without adverse ophthalmological outcome (stage ≥ 3, AP-ROP, or any ROP treatment) (time frame: 48 weeks postmenstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03083431, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.