A clinical study of the FAI Insert in patients with uveitis in the back of the eye that is not caused by an infectio

Conditions: chronic non-infectious uveitis affecting the posterior segment of the eye
MedDRA version: 16.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2013-001810-14-IT

Lead Sponsor: pSivida Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

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 < 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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
• Media opacity precluding evaluation of retina and vitreous
• Peripheral retinal detachment in area of insertion
• Current diagnosis of any form of glaucoma
• Intraocular pressure (IOP) > 21 mmHg or concurrent therapy at screening with any IOP-lowering agent in the study eye
• Chronic hypotony (< 6 mmHg)
• Ocular surgery on the study eye within 3 months prior to study Day 1
• Capsulotomy in study eye within 30 days prior to study Day 1
• Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1
• Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1
• Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1
• Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1
• Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or systemic immunosuppressive therapy to manage non-ocular disease
• 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 have tested positive for human immune deficiency virus (HIV)
• 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 30 days prior to study Day 1
• Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit
• Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years