Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (NCT01694186) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
United States, Germany, Hungary129 participantsStarted 2013-08-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Male or non-pregnant female at least 18 years of age at time of consent
* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \> 1 year duration.
* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:
* systemic corticosteroid or other systemic therapies given for at least 3 months, and/or
* at least 2 intra- or peri-ocular injections of corticosteroid for management of uveitis
OR the study eye has experienced recurrence:
* at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid
* At the time of enrollment (Day 1), study eye has \< 10 anterior chamber cells/HPF and a vitreous haze ≤ grade 2.
* Visual acuity of study eye is at least 15 letters on the ETDRS chart
* Subject is not planning to undergo elective ocular surgery during the study
* Subject has ability to understand and sign the Informed Consent Form
* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria
* Allergy to fluocinolone acetonide or any component of the FAI insert
* History of posterior uveitis only that is not accompanied by vitritis or macular edema
* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze
* Uveitis with infectious etiology
* Vitreous hemorrhage
* Intraocular …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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