Phase 2
Completed N=121
IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
Retinopathy of Prematurity (ROP)
Source: ClinicalTrials.gov NCT01096784 ↗
Enrolled (actual)
121
Serious AEs
70.3%
Results posted
Jun 2017
Primary outcomePrimary: Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population — 14; 24; 4; 4 participants — p=0.0642
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population |
14; 24; 4; 4; 17; 13 | 0.0642 |
| SECONDARY Time to Discharge From Neonatal Intensive Care (TDNIC) |
82.00; 74.00 | — |
| SECONDARY Number of Participants With Bronchopulmonary Dysplasia (BPD) |
4; 4; 23; 16; 9; 5 | — |
| SECONDARY Rate of Change in Body Weight |
0.021; 0.023 | — |
| SECONDARY Rate of Change in Length |
0.141; 0.156 | — |
| SECONDARY Rate of Change in Head Circumference |
0.115; 0.119 | — |
| SECONDARY Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS |
87.94; 93.70; 206.34; 221.98; 110.23; 117.62 | — |
| SECONDARY Percentage of Participants With Intraventricular Hemorrhage (IVH) |
19.67; 30.0; 80.33; 70.0 | — |
| SECONDARY Area Under Curve for Maximum Severity of ROP Stage (AUC for ROP) |
47.95; 32.17 | — |
| SECONDARY Percentage of Participants With Maximum Severity of ROP Stage Greater Than or Equal to 3 at Any Time During the Study |
25.53; 18.00; 74.47; 82.00 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) |
60; 60; 48; 37 | — |
| SECONDARY Percentage of Serum IGF-1 Concentrations Falling Within Target Range After Infusion of rhIGF-1/rhIGFBP-3 |
66.23; 6.28 | — |
| SECONDARY Serum Concentrations of IGFBP-3 After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3 |
494.2; 469.9; 830.1; 882.1 | — |
| SECONDARY Serum Concentrations of Acid Labile Sub-unit (ALS) After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3 |
411.9; 500.3; 1804.6; 2114.3 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01096784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.