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

Phase 1

• Conditions: RETINOPATHY OF PREMATURITY; MedDRA version: 20.1Level: PTClassification code 10038933Term: Retinopathy of prematuritySystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-005472-29-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

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

Newborns with:
1. cardiac failure
2. recurrent episodes of bradycardia (BPM < 90)
3. atrioventricular block 2nd and/or 3rd degrees
4. significant cardiovascular congenital anomalies (except of patent foramen ovale, patent ductus arteriosus o defects of the interventricular septum)
5. hypotension
6. serious renal failure
7. cerebral bleeding (ongoing)
8. other diseases for which the use of beta blockers is contraindicated
9. ROP stage > 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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<br>2. 10 days from the beginning of the treatment

Secondary Outcome Measures

Name	Time	Method
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