Completed

DROP-PROPSafety and Efficacy of Propranolol Eye Drops in Newborns With Retinopathy of Premature (DROP-PROP)

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What is being tested

Propranolol eye drops

Drug
Who is being recruted

Eye Diseases+8

+ Infant, Newborn, Diseases

+ Infant, Premature, Diseases

From 1 to 4 Months
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2013
See protocol details

Summary

Principal SponsorMeyer Children's Hospital IRCCS
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2013

Actual date on which the first participant was enrolled.

The aim of the present study is to evaluate the safety and efficacy of propranolol eye drops in preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 2 ROP (zone II without plus) will receive propranolol eye drops treatment until retinal vascularization will be completed. Propranolol concentrations will be measured on dried blood spots during the first 3 days of treatment and at the steady state. Cardiovascular and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.

Official TitleSafety and Efficacy of Propranolol Eye Drops in Newborns With Retinopathy of Premature (DROP-PROP)
NCT02014454
Principal SponsorMeyer Children's Hospital IRCCS
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 4 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesInfant, Newborn, DiseasesInfant, Premature, DiseasesMetaplasiaCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeovascularization, PathologicPathologic ProcessesRetinal DiseasesRetinopathy of PrematurityPathological Conditions, Signs and SymptomsRetinal Neovascularization

Criteria

2 inclusion criteria required to participate
Preterm newborns (gestational age 23-32 weeks) with stage 2 ROP, zone II without plus.
A signed parental informed consent.
8 exclusion criteria prevent from participating
Newborns with heart failure;
Newborns with congenital cardiovascular anomalies, except for persistent ductus arteriosus, patent foramen ovale and small ventricular septal defects;
Newborns with recurrent bradycardia (heart rate < 90 beat per minute);
Newborns with second or third degree atrioventricular block;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All the enrolled preterm newborns will receive propranolol as ophthalmic solution (0,1%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, three times daily (every 8 hours).The treatment will continue until the complete development of retinal vascularization, but no more than 60 days. The propranolol treatment will be always associated to the conventional approach adopted by the Early Treatment for Retinopathy of Prematurity Study (ETROP Cooperative Group.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital

Florence, ItalyOpen Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital in Google Maps
Suspended

Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan

Milan, Italy
Completed2 Study Centers