Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 3 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Hospital Tübingen
RECRUITING
Tübingen
Switzerland
University Hospital Zurich
RECRUITING
Zurich
Turkey
Ankara University School of Medicine Children's Hospital
RECRUITING
Ankara
Contact Information
Primary
Dirk Bassler, M.D.
dirk.bassler@usz.ch
+41 44 255 53 40
Backup
Christoph Rüegger, M.D.
christoph.rueegger@usz.ch
+41 43 253 98 10
Time Frame
Start Date: 2022-09-22
Estimated Completion Date: 2026-07
Participants
Target number of participants: 276
Treatments
Experimental: Propranolol
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)
Placebo_comparator: Placebo
Placebo (same duration as oral propranolol solution)
Sponsors
Collaborators: University Hospital Tuebingen, Ankara University
Leads: University of Zurich

This content was sourced from clinicaltrials.gov