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NCT01694186 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
A Phase 3 study of Non-infectious Uveitis, sponsored by EyePoint Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 129
- Enrollment target
- 20
- Study locations
NCT01694186: Completed Phase 3 study of Non-infectious Uveitis, sponsored by EyePoint Pharmaceuticals.
NCT01694186 is a Phase 3 study of Non-infectious Uveitis that has completed, run by EyePoint Pharmaceuticals. The registered enrollment target is 129 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01694186, a Phase 3 study of Non-infectious Uveitis, has completed, sponsored by EyePoint Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 129 participants
- Enrollment target
- 20
- Study locations
Study Summary
A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.
Primary Outcome
Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.
Conditions Studied
Interventions
- DRUG FAI insert
- DRUG Sham injection
Study Locations (20)
California
- Retina Vitreaous Associates - Beverly Hills
- Retinal Consultants Medical Group, Inc - Sacramento
- Retina Macula Institute - Torrance
Texas
- Texas Retina Associates - Arlington
- Retina Consultants of Houston - Houston
- Foresight Studies, LLC - San Antonio
Other
- Augenarzte am St. Franziskus Hospital - Münster
- Universitatsklinikum Tubingen - Tübingen
- Bajcsy-Zsilinszky Kórház és Rendelőintézet - Budapest
Colorado
- Retina Consultants of Southern Colorado - Colorado Springs
Illinois
- Northwestern University - Chicago
Kentucky
- Ophthalmology & Visual Sciences - Lexington
Massachusetts
- Ocular Immunology and Uveitis Foundation - Cambridge
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2013-08-02 |
| Est. Completion | 2018-03-26 |
| Phase | Phase 3 |
What the finished NCT01694186 record still lists
NCT01694186 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Non-infectious Uveitis appearing as the primary indexed condition, and to 2 interventions - of which FAI insert is the first listed.
NCT01694186 names 20 study sites across 14 states, led by California, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT01694186 about?
NCT01694186 is a clinical study titled "Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert". A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.
What is the current status of trial NCT01694186?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2013-08-02. Estimated completion is 2018-03-26.
What conditions does trial NCT01694186 study?
This clinical trial studies the following conditions: Non-infectious Uveitis.
What interventions are being tested in trial NCT01694186?
The interventions under investigation include: FAI insert (DRUG), Sham injection (DRUG).
Who is sponsoring clinical trial NCT01694186?
This trial is sponsored by EyePoint Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01694186 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01694186's enrollment target sits among peer trials
129 1597th of 2000 higher than 400 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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