Long-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care (PEDAL)
Phase of Trial: Phase II
Latest Information Update: 30 Sep 2017
At a glance
- Drugs Mecasermin rinfabate (Primary)
- Indications Retinopathy of prematurity
- Focus Adverse reactions; Therapeutic Use
- Acronyms PEDAL
- Sponsors Premacure; Shire
- 17 Nov 2016 Planned number of patients changed from 120 to 98.
- 17 Nov 2016 Planned End Date changed from 1 Apr 2021 to 1 Sep 2021.
- 17 Nov 2016 Planned primary completion date changed from 1 Jan 2021 to 1 Aug 2021.