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NCT01096784 · ClinicalTrials.gov registry record · Phase 2
IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
NCT01096784: Completed Phase 2 study, sponsored by Shire.
NCT01096784 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 121 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01096784, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG rhIGF-I/rhIGFBP-3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2010-06-18 |
| Est. Completion | 2016-03-30 |
| Phase | Phase 2 |
What the finished NCT01096784 record still lists
NCT01096784 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which rhIGF-I/rhIGFBP-3 is the first listed.
NCT01096784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01096784 about?
NCT01096784 is a clinical study titled "IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity". 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.
What is the current status of trial NCT01096784?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2010-06-18. Estimated completion is 2016-03-30.
What interventions are being tested in trial NCT01096784?
The interventions under investigation include: rhIGF-I/rhIGFBP-3 (DRUG).
Who is sponsoring clinical trial NCT01096784?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01096784's enrollment target sits among peer trials
121 567th of 2000 higher than 1,432 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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