At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 121 enrolled
Drug / intervention
rhIGF-I/rhIGFBP-3drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Determination of the rhIGF-1/rhIGFBP-3 Dose, Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal Serum IGF-1 Levels Within Physiological Levels in Premature Infants, to Prevent Retinopathy of Prematurity A Phase 2, Randomized Controlled, Assessor-blind, Dose Confirming, Pharmacokinetic, Safety and Efficacy, Multicenter Study
In Brief
A Phase 2 clinical trial evaluating rhIGF-I/rhIGFBP-3 for Retinopathy of Prematurity (ROP). Completed, enrolled 121 participants across 24 sites in 6 countries.
Detailed Summary
To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for gestational age at birth while confirming the dose of rhIGF-1/rhIGFBP-3 is safe and efficacious.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinopathy of Prematurity (ROP)
CountriesItaly, Netherlands, Poland, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartJun 2010
Primary CompletionMar 2016
TodayJul 2026
First PostedMar 31, 2010
Enrollment StartJun 18, 2010
Primary CompletionMar 30, 2016
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 16.3 years ago
Interventions
rhIGF-I/rhIGFBP-3drug
Continuous intravenous infusion