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NCT02251938 · ClinicalTrials.gov registry record · Phase 3
A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
A Phase 3 study of Non-Infectious Uveitis of the Posterior Segment of the Eye, sponsored by Santen.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT02251938: Completed Phase 3 study of Non-Infectious Uveitis of the Posterior Segment of the Eye, sponsored by Santen.
NCT02251938 is a Phase 3 study of Non-Infectious Uveitis of the Posterior Segment of the Eye that has completed, run by Santen. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02251938, a Phase 3 study of Non-Infectious Uveitis of the Posterior Segment of the Eye, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.
Primary Outcome
Best Corrected Visual Acuity (BCVA) measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters. An increase in BCVA indicates improvement in the best-corrected vision. A BCVA score of 85 ETDRS letters is equivalent to 20/20 vision, which is considered normal vision.
Conditions Studied
Interventions
- DRUG DE-109 440 μg
Study Locations (20)
New Jersey
- - New Brunswick
- - Palisades Park
New York
- - New York
- - Orchard Park
Other
- - Graz
- - Paris
New Dehli
- - Aurobindo Marg
- - Daryāganj
Arizona
- - Phoenix
California
- - Sacramento
Colorado
- - Golden
Florida
- - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-09-29 |
| Est. Completion | 2017-11-27 |
| Phase | Phase 3 |
What the finished NCT02251938 record still lists
NCT02251938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Non-Infectious Uveitis of the Posterior Segment of the Eye appearing as the primary indexed condition, and to 1 intervention - of which DE-109 440 μg is the first listed.
NCT02251938 names 20 study sites across 16 states, led by New Jersey, New York, Other.
Frequently Asked Questions
What is clinical trial NCT02251938 about?
NCT02251938 is a clinical study titled "A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program". The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.
What is the current status of trial NCT02251938?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2014-09-29. Estimated completion is 2017-11-27.
What conditions does trial NCT02251938 study?
This clinical trial studies the following conditions: Non-Infectious Uveitis of the Posterior Segment of the Eye.
What interventions are being tested in trial NCT02251938?
The interventions under investigation include: DE-109 440 μg (DRUG).
Who is sponsoring clinical trial NCT02251938?
This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02251938 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02251938's enrollment target sits among peer trials
60 1804th of 2000 higher than 177 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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