MedTrace Logo

Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

NCT03083431 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity

Interventions

DRUG

Propranolol

Oral propranolol (1.6 mg propranolol-hydrochloride/kg/d in 4 divided dosages)

DRUG

Placebo

Oral solution containing the same excipients as propranolol solution

Sponsors & Collaborators

  • Ankara University

    collaborator OTHER

  • University Hospital Tuebingen

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Dirk Bassler, M.D. · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Weeks
Max Age
15 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Germany
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083431 on ClinicalTrials.gov