Clinical trial NCT02748512: Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis
Official title: A Controlled, Multi-Center Study of the Utilization and Safety of the MkII Inserter and the Safety of the FAI Insert in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Infectious Uveitis
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the Mk II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.

Detailed description: This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the MK II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.

Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female at least 18 years of age at time of consent
2. At least one eye has a history of non-infectious uveitis affecting the posterior segment
3. Subject has ability to understand and sign the Informed Consent Form
4. Subject is willing and able to comply with study requirements

Exclusion Criteria:

1. Allergy to fluocinolone acetonide or any component of the FAI insert
2. Ocular malignancy in either eye, including choroidal melanoma
3. Uveitis with infectious etiology
4. Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
5. Current mycobacterial infections of the eye or fungal diseases of ocular structures
6. Subjects who yield, during screening, a confirmed positive test for human immune deficiency virus (HIV) or syphilis
7. Systemic infection within 30 days prior to study Day 1
8. Peripheral retinal detachment in area of insertion
9. Elevated intraocular pressure (IOP) \> 21 mmHg, or chronic hypotony \< 6 mmHg
10. Concurrent therapy at screening with IOP-lowering pharmacologic agent in the study eye
11. Current 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 (10-21 mmHg)
12. Known history of clinically significant IOP elevation in response to steroid treatment in either eye, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmHg)
13. Ocular surgery or capsulotomy performed on the study eye within 30 days prior to study Day 1
14. Intravitreal treatment of study eye: with FAI insert within 36 months prior to study Day 1;with Retisert within 30 months prior to study Day 1; with Ozurdex within 90 days prior to study Day 1; or with Triesence or Trivaris within 30 days prior to study Day 1
15. Peri-ocular or subtenon steroid treatment of study eye within 30 days prior to study Day 1
16. Treatment with an investigational drug or device within 30 days prior to study Day 1, except the FAI insert within this protocol
17. 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
18. Any condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study

Primary outcomes:
measure: The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment.
timeFrame: Day 7
Secondary outcomes:
measure: The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages.
timeFrame: Month 12
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado, PC
state: Colorado
city: Waltham
country: United States
facility: Massachusetts Eye Research and Surgery Institution / Ocular Immunology & Uveitis Foundation
state: Massachusetts
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Cole Eye Institute
state: Ohio
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
Study officials:
affiliation: pSivida Corp, Senior Manager, Clinical Affairs
name: Flavio Leonin Jr., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: pSivida Corp, Vice President, Regulatory Affairs
name: Gerard E Riedel, PhD
role: STUDY_CHAIR
affiliation: pSivida Corp, Chief Executive Officer
name: Paul Ashton, PhD
role: STUDY_DIRECTOR
References: