Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis

Completed · Phase 3

Conditions studied: Non-Infectious Uveitis

In brief

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.

Key facts

Study ID

NCT02748512

Run by

EyePoint Pharmaceuticals, Inc.

People needed

26

Starts

2016-02-23

Expected to finish

2017-08-17

Last updated by the study team

2020-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Allergy to fluocinolone acetonide or any component of the FAI insert
• Ocular malignancy in either eye, including choroidal melanoma
• Uveitis with infectious etiology
• Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
• Current mycobacterial infections of the eye or fungal diseases of ocular structures
• Subjects who yield, during screening, a confirmed positive test for human immune deficiency virus (HIV) or syphilis
• Systemic infection within 30 days prior to study Day 1
• Peripheral retinal detachment in area of insertion
• Elevated intraocular pressure (IOP) > 21 mmHg, or chronic hypotony < 6 mmHg
• Concurrent therapy at screening with IOP-lowering pharmacologic agent in the study eye
• 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)
• 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)
• Ocular surgery or capsulotomy performed on the study eye within 30 days prior to study Day 1
• 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
• Peri-ocular or subtenon steroid treatment of study eye within 30 days prior to study Day 1
• Treatment with an investigational drug or device within 30 days prior to study Day 1, except the FAI insert within this protocol
• 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
• Any condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study

Where it is running

• Retina Consultants of Southern Colorado, PC — Colorado Springs, Colorado, United States
• Massachusetts Eye Research and Surgery Institution / Ocular Immunology & Uveitis Foundation — Waltham, Massachusetts, United States
• Duke Eye Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation Cole Eye Institute — Cleveland, Ohio, United States
• Charleston Neuroscience Institute — Ladson, South Carolina, United States
• Texas Retina Associates — Arlington, Texas, United States

Full record on ClinicalTrials.gov

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