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NCT02386839 · ClinicalTrials.gov registry record · Phase 2
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT02386839: Completed Phase 2 study, sponsored by Shire.
NCT02386839 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02386839, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
Primary Outcome
Standard age-appropriate methods were used to assess visual acuity (how well a participant sees at different distances) with teller acuity cards, LEA symbols test and Charts. It was categorized as following: normal (measurable acuity \>= 20/40 or \>= 15 cycles/degree); below normal (20/200 \<= measurable acuity \< 20/40 or 3 cycles/degree \<= measurable acuity \< 15 cycles/degree); poor (measurable acuity \<= 20/200 or \<= 3 cycles/degree). Corrected Age (weeks) was defined as Chronological Age
Interventions
- DRUG rhIGF-1/rhIGFBP-3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2015-03-26 |
| Est. Completion | 2021-09-28 |
| Phase | Phase 2 |
What the finished NCT02386839 record still lists
NCT02386839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which rhIGF-1/rhIGFBP-3 is the first listed.
NCT02386839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02386839 about?
NCT02386839 is a clinical study titled "Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)". The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
What is the current status of trial NCT02386839?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2015-03-26. Estimated completion is 2021-09-28.
What interventions are being tested in trial NCT02386839?
The interventions under investigation include: rhIGF-1/rhIGFBP-3 (DRUG).
Who is sponsoring clinical trial NCT02386839?
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 NCT02386839's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 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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