Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
- Conditions
- Non-Infectious Uveitis
- Interventions
- Drug: Sham injectionDrug: FAI insert
- Registration Number
- NCT01694186
- Lead Sponsor
- EyePoint Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham injection Sham injection sham injection FAI insert FAI insert FAI insert (0.18 mg fluocinolone acetonide)
- Primary Outcome Measures
Name Time Method Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit 36 months 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (34)
Retina Vitreaous Associates
🇺🇸Beverly Hills, California, United States
Retinal Consultants Medical Group, Inc
🇺🇸Sacramento, California, United States
Retina Macula Institute
🇺🇸Torrance, California, United States
Retina Consultants of Southern Colorado
🇺🇸Colorado Springs, Colorado, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Ophthalmology & Visual Sciences
🇺🇸Lexington, Kentucky, United States
Ocular Immunology and Uveitis Foundation
🇺🇸Cambridge, Massachusetts, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Retina Consultants
🇺🇸Slingerlands, New York, United States
Duke University Eye Center
🇺🇸Durham, North Carolina, United States
Scroll for more (24 remaining)Retina Vitreaous Associates🇺🇸Beverly Hills, California, United States