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IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity

NCT01096784 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2021-06-14

Study results available
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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.

Conditions

  • Retinopathy of Prematurity (ROP)

Interventions

DRUG

rhIGF-I/rhIGFBP-3

Continuous intravenous infusion

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-18
Primary Completion
2016-03-30
Completion
2016-03-30

Countries

  • United States
  • Italy
  • Netherlands
  • Poland
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096784 on ClinicalTrials.gov