Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01096784 | IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity | PHASE2 | COMPLETED | 121 | — | — | Jun 18, 2010 | Mar 30, 2016 | Jun 14, 2021 | 24 | United States, Italy +4 |
ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome. The maximum severity of ROP across all time points was assessed from 31 PMA weeks up to 40 PMA Weeks +/- 4 days (end of study).
| Arm | Type | Description |
|---|---|---|
| rhIGF-I/rhIGFBP-3 | ACTIVE_COMPARATOR | Continuous IV Infusion |
| Control | NO_INTERVENTION | The comparator group will receive no treatment with rhIGF-1/rhIGFBP-3 |
| Name | Type | Description |
|---|---|---|
| rhIGF-I/rhIGFBP-3 | DRUG | Continuous intravenous infusion |
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 smal...