Trials / Completed
CompletedNCT01694186
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- EyePoint Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FAI insert | |
| DRUG | Sham injection |
Timeline
- Start date
- 2013-08-02
- Primary completion
- 2018-03-26
- Completion
- 2018-03-26
- First posted
- 2012-09-27
- Last updated
- 2021-04-02
- Results posted
- 2020-03-23
Locations
34 sites across 6 countries: United States, Germany, Hungary, India, Israel, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01694186. Inclusion in this directory is not an endorsement.