Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis (NCT02746991) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis
India153 participantsStarted 2015-06-02
Plain-language summary
Phase 3, 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 chronic 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.
Who can participate
Age range18 Years
SexALL
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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
* At the time of enrollment (Day 1), study eye has \< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.
* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (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
* 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 administrations 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
Exclusion Criteria:
* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert
* History of posterior uveitis only that is not accompanied by vitritis or macular edema
* History of iritis only and no vitreous cells,…
What they're measuring
1
Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months