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Oral propranolol for prevention of threshold retinopathy of prematurity

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511338-10-01
Acronym
ROPROP
Enrollment
100
Registered
2024-10-24
Start date
2024-07-24
Completion date
Unknown
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of prematurity

Brief summary

Survival without threshold ROP (stage 3 or more severe ROP(including aggressive posterior ROP))

Detailed description

Time to adverse ophthalmological outcome in days, Ophthalmological outcome categorized as survival without adverse ophthalmological outcome, or death, Survival until 48 weeks PMA without ROP, treated with ablative laser surgery or intravitreal VEGF antagonists, Death until discharge, Death until 48 weeks PMA, ROP retreatment: Need for repeated ROP therapy in infants treated with anti-VEGF-antagonists until 70 ( 2 weeks) PMA

Interventions

DRUGComposition
DRUGidentical to the IMP
DRUGPROPRANOLOL HYDROCHLORIDE

Sponsors

Universitaetsklinikum Tuebingen AöR, Universität Zürich - Klinik für Neonatologie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Survival without threshold ROP (stage 3 or more severe ROP(including aggressive posterior ROP))

Secondary

MeasureTime frame
Time to adverse ophthalmological outcome in days, Ophthalmological outcome categorized as survival without adverse ophthalmological outcome, or death, Survival until 48 weeks PMA without ROP, treated with ablative laser surgery or intravitreal VEGF antagonists, Death until discharge, Death until 48 weeks PMA, ROP retreatment: Need for repeated ROP therapy in infants treated with anti-VEGF-antagonists until 70 ( 2 weeks) PMA

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026