chronic non-infectious uveitis affecting the posterior segment of the eye MedDRA version: 19.0 Level: PT Classification code 10046851 Term: Uveitis System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Iluvien
Product Name: Fluocinolone Acetonide Intravitreal insert
Product Code: FAI insert
Pharmaceutical Form: Intravitreal implant in appli
Sponsors
pSivida Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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: o systemic corticosteroid or other systemic therapies given for at least 3 months, and/or o at least 2 intra- or peri-ocular injections of corticosteroid for management of uveitis OR the study eye has experienced recurrence: o at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid • At the time of enrollment (Day1), study eye has =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma) • Ocular malignancy in either eye, including choroidal melanoma • Toxoplasmosis scar in study eye; or scar related to previous viral retinitis • Previous viral retinitis •Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structure • Media opacity precluding evaluation of retina and vitreous • Peripheral retinal detachment in area of insertion • Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-20 mmHG) at Screening • Intraocular pressure (IOP) > 21 mmHg or concurrent therapy at screening with any IOP-lowering pharmacologic agent in the study eye • Chronic hypotony (15mg prednisone daily) or chronic systemic immunosuppressive therapy • Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1 •Subjects who test positive for human immune deficiency virus (HIV) or syphilis during screening •Mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis • Systemic infection within 30 days prior to study Day 1 • Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study • Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study • Treatment with an investigational drug or device within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to evaluate the safety and efficacy of a FAI insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye.;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: 6 months after receiving study treatment; Primary end point(s): Efficacy: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment. Recurrence is defined as: • A > 2 step increase in the number of cells in the anterior chamber per high powered field (1.6 X using a 1-mm beam), compared to any visit time point prior to Month 6 OR • An increase in the vitreous haze of > 2 steps, compared to any visit time point prior to Month 6 OR • A deterioration in visual acuity of at least 15 letters BCVA, compared to any visit time point prior to Month 6 Safety: • Systemic adverse events • 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory Efficacy Endpoints: • Proportion of subjects who have a recurrence of uveitis in the study eye within 12 months or 36 months • Proportion of subjects who have a recurrence of uveitis in the fellow eye (within 6 months, 12 months and 36 months) • Mean change from baseline in BCVA letter score in the study eye (at 6 months, 12 months and 36 months) • Number of recurrences of uveitis (within 6 months, 12 months and 36 months) • Time to recurrence of uveitis (within 6 months, 2 months and 36 months) • Number of adjunctive treatments required to treat recurrences of uveitis (within 6 months, 12 months and 36 months) • Resolution of macular edema, as measured by OCT imaging (at 6 months, 12 months and 36 months) ;Timepoint(s) of evaluation of this end point: Within 6, 12 and/or 36 months after receiving study treatment | — |
Countries
Germany, Hungary, India, Israel, Italy, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Information
pSivida Corporation
Outcome results
None listed