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NCT02344225 · ClinicalTrials.gov registry record · Phase 2
Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)
A Phase 2 study, sponsored by State University of New York - Downstate Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT02344225: Completed Phase 2 study, sponsored by State University of New York - Downstate Medical Center.
NCT02344225 is a Phase 2 study that has completed, run by State University of New York - Downstate Medical Center. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02344225, a Phase 2 study, has completed, sponsored by State University of New York - Downstate Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP. This study was designed to: a) target infants at the highest risk of ROP in a large number of centers with variable rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study is designed to determine whether the novel treatment regimens are safe and potentially effective for ROP prevention and to obtain requisite data for the development of a Phase III efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as standard of care for ELGANs, no placebo group is included.
Primary Outcome
ROP (all grades) will be graded using International ROP Classification and severe ROP (Stage 3+ disease) or need for laser or Avastin The rate of mild (stage 1), moderate (stage 2) and severe ROP (stages \>3) will be calculated as the number of infants diagnosed with ROP over the number of infants receiving retinal examinations. The study enrolled only 14 of the projected sample of 120, and the low enrollment did not allow meaningful analyses of efficacy and safety.
Interventions
- DRUG Ketorolac
- DRUG Ibuprofen
- DRUG Caffeine citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-01-01 |
| Est. Completion | 2018-06-30 |
| Phase | Phase 2 |
What the finished NCT02344225 record still lists
NCT02344225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Ketorolac is the first listed.
NCT02344225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02344225 about?
NCT02344225 is a clinical study titled "Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)". Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP. This study was designed to: a) target infants at the highest risk of ROP in a large number of centers with variable rates of ROP (all stage...
What is the current status of trial NCT02344225?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2015-01-01. Estimated completion is 2018-06-30.
What interventions are being tested in trial NCT02344225?
The interventions under investigation include: Ketorolac (DRUG), Ibuprofen (DRUG), Caffeine citrate (DRUG).
Who is sponsoring clinical trial NCT02344225?
This trial is sponsored by State University of New York - Downstate Medical Center, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02344225's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 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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