Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03083431
Study type	Interventional
Source	University of Zurich
Contact	Dirk Bassler, M.D.
Phone	+41 44 255 53 40
Email	dirk.bassler@usz.ch
Status	Recruiting
Phase	Phase 2
Start date	September 22, 2022
Completion date	July 2026

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See also
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Active, not recruiting	`NCT00027222` - The Early Treatment for Retinopathy of Prematurity Study (ETROP)	Phase 2/Phase 3
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Completed	`NCT01861470` - REDEXAM - Reducing Painful Eye Examinations in Preterm Infants	N/A
Completed	`NCT02014454` - Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature	Phase 2
Terminated	`NCT00634972` - Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity	Phase 4
Completed	`NCT05701124` - Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity	Phase 3
Completed	`NCT04092127` - Pain of Premature Babies and RetCam (DOLICAM)
Completed	`NCT04621136` - PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity	Phase 1/Phase 2
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity — RoProp

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms