NCT03083431

Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 5 Weeks – 15 Weeks
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-22
• Primary completion: 2025-12-01
• Completion: 2026-07-01
• First posted: 2017-03-20
• Last updated: 2024-12-12

Locations

3 sites across 3 countries: Germany, Switzerland, Turkey (Türkiye)