Clinical Trial

Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

Study acronym: RoProp
Recruiting Phase 2
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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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2017-03-13; most recent amendment 2026-05-04.
Status change: Not Yet Recruiting → Recruiting 2022-10-03
Status change: Withdrawn → Not Yet Recruiting 2022-07-24
Status change: Not Yet Recruiting → Withdrawn 2021-03-29
Trial Details
NCT Number NCT03083431
Lead Sponsor University of Zurich
Collaborators: Ankara University, University Hospital Tuebingen
Conditions Retinopathy of Prematurity
Enrollment 276 participants
Start Date 2022-09-22
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-07