Safety and efficacy of propranolol eye drops in neonates with retinopathy of prematurity: a pilot study (DROP-ROP).
- Conditions
- The medical condition to be investigated is Retinopathy of Prematurity (ROP)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-002062-39-IT
- Lead Sponsor
- Azienda Ospedaliero-Universitaria Meyer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Preterm newborns (gestational age lower than 32 weeks) who develop stage 2 ROP (zone II without plus).
Are the trial subjects under 18? yes
Number of subjects for this age range: 55
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
1. Newborns with heart failure, bradycardia, atrioventricular blocks, congenital cardiovascular anomalies, hypotension, renal failure, failure to thrive, cerebral haemorrhage, other diseases that contraindicate the use of beta-blockers.
2. Newborns with ROP at a more advanced stage than stage 2 (zone II without plus).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable;Main Objective: To reduce the progression of Retinopathy of Prematurity;Primary end point(s): 1. To evaluate the efficacy of propranolol to reduce the progression of ROP to stage 2 or 3 with plus.<br><br>2. To evaluate the plasma levels of propranolol in newborns enrolled<br><br>;Timepoint(s) of evaluation of this end point: 60 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. To evaluate the efficacy of propranolol to reduce the progression of ROP to stage 4 or 5.<br><br>2. To evaluate the number of newborns treated with laser<br><br>;Timepoint(s) of evaluation of this end point: 60 days