Safety and efficay of 0.2% propranolol eye drops in newborns with retinopathy of prematurity

Safety and efficay of 0.2% propranolol eye drops in newborns with retinopathy of prematurity: a pilot study - na

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005472-29-IT

Enrollment

Registered

2020-11-04

Start date

2015-06-10

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RETINOPATHY OF PREMATURITY MedDRA version: 20.1 Level: PT Classification code 10038933 Term: Retinopathy of prematurity System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: na Product Name: na Product Code: na Pharmaceutical Form: Eye drops, solution INN or Proposed INN: PROPRANOLOLO Current Sponsor code: PROPRANOLOLO Other descriptive name: PROPRANOLOL Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newborns with gestational ages between 23 and 32 weeks affected by classic stage 1 ROP. 2. Parents informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Newborns with: 1. cardiac failure 2. recurrent episodes of bradycardia (BPM 1

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the safety and efficacy of 0.2% propranolol eye drops to stop the progression of classic retinopathy of prematury (ROP) stage 1 towards stage 2 plus or stage 3 plus, therefore avoiding interventions such as laser therapy or anti-VEGF therapy.;Secondary Objective: Evaluate the efficacy of 0.2% propranolol eye drops to stop the progression of classic retinopathy of prematury (ROP) stage 1 towards subsequent stages;Primary end point(s): 1. Proportion of newborns who progress to stage 2 plus or 3 plus ROP zone II 2. Measurement of haematic propranolol concentration after 10 days of treatment (steady state);Timepoint(s) of evaluation of this end point: 1. maximun 90 days 2. 10 days from the beginning of the treatment	—

Measure

Time frame

Main Objective: Evaluate the safety and efficacy of 0.2% propranolol eye drops to stop the progression of classic retinopathy of prematury (ROP) stage 1 towards stage 2 plus or stage 3 plus, therefore avoiding interventions such as laser therapy or anti-VEGF therapy.;Secondary Objective: Evaluate the efficacy of 0.2% propranolol eye drops to stop the progression of classic retinopathy of prematury (ROP) stage 1 towards subsequent stages;Primary end point(s): 1. Proportion of newborns who progress to stage 2 plus or 3 plus ROP zone II 2. Measurement of haematic propranolol concentration after 10 days of treatment (steady state);Timepoint(s) of evaluation of this end point: 1. maximun 90 days 2. 10 days from the beginning of the treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of newborns who progress to stage 2 without plus ; Proportion of newborns who progress to stage 3 without plus ; Proportion of newborns who progress to stage 4 and 5 and experiencing partial or total retinal detachment; Proportion of newborns who need vitrectomy ; Frequency of adverse events;Timepoint(s) of evaluation of this end point: maximum 90 days; maximum 90 days; maximum 90 days; maximum 90 days; Continuous safety monitoring for the entire length of the treatment	—

Measure

Time frame

Secondary end point(s): Proportion of newborns who progress to stage 2 without plus ; Proportion of newborns who progress to stage 3 without plus ; Proportion of newborns who progress to stage 4 and 5 and experiencing partial or total retinal detachment; Proportion of newborns who need vitrectomy ; Frequency of adverse events;Timepoint(s) of evaluation of this end point: maximum 90 days; maximum 90 days; maximum 90 days; maximum 90 days; Continuous safety monitoring for the entire length of the treatment

—

Countries

Italy

Contacts

Public ContactCLINICAL TRIAL OFFICE

AZIENDA OSPEDALIERO UNIVERSITARIA MEYER

clinicaltrialoffice@meyer.it0555662425

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026