At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 76 enrolled
Drug / intervention
rhIGF-1/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.
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
In Brief
A Phase 2 clinical trial evaluating rhIGF-1/rhIGFBP-3 for Retinopathy of Prematurity (ROP). Completed, enrolled 76 participants across 16 sites in 6 countries.
Detailed Summary
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinopathy of Prematurity (ROP)
CountriesItaly, Netherlands, Poland, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartMar 2015
Primary CompletionSep 2021
TodayJul 2026
First PostedMar 12, 2015
Enrollment StartMar 26, 2015
Primary CompletionSep 28, 2021
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 11.3 years ago
Interventions
rhIGF-1/rhIGFBP-3drug
Participants who received "rhIGF-1/rhIGFBP-3" in study ROPP-2008-01 (NCT01096784) will be enrolled to this study. No investigational product will be administered in this study.