CompletedPhase 3

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

United States26 participantsStarted 2016-02-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment.

Timeframe: Day 7

Trial details

NCT IDNCT02748512

SponsorEyePoint Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-08-17

Results submitted2020-01-29

View on ClinicalTrials.gov More Non-Infectious Uveitis trials