IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity

• Status: Completed
• Trial end date: 2016-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Mecasermin

Criteria

Inclusion Criteria:

• Signed informed consent from parents/guardians;

• Subject must be between GA of 26 weeks + 0 days and 27 weeks + 6 days (Study Section A) or between GA of 23 weeks + 0 days and 27 weeks + 6 days (Study Sections B, C, and D), inclusive

Exclusion Criteria:

• Subjects born small for gestational age (SGA), ie, body weight at birth <-2 standard deviation score (SDS) (Study Section A only)

• Detectable gross malformation

• Known or suspected chromosomal abnormality, genetic disorder, or syndrome, according to the Investigator's opinion

• Persistent blood glucose level <2.5 mmol/L or >10 mmol/L at Study Day 0 (day of birth) to exclude severe congenital abnormalities of glucose metabolism

• Anticipated need of administration of erythropoietin (rhEPO) during treatment with study drug.

• Any maternal diabetes requiring insulin during the pregnancy

• Clinically significant neurological disease according to the Investigator's opinion(Stage 1 IVH allowed)

• Any other condition or therapy that, in the Investigator's opinion, may pose a risk to the subject or interfere with the subject's ability to be compliant with this protocol or interfere with interpretation of results

• Monozygotic twins

• Subject participating or plans to participate in a clinical study of another investigational study drug