Status and phase
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About
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.
Full description
This is a 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.
Enrollment
Sex
Ages
Volunteers
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:
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
Primary purpose
Allocation
Interventional model
Masking
153 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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