Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:June 2013
End Date:December 2018

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A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to
evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI)
insert for the management of subjects with non-infectious uveitis affecting the posterior
segment of the eye. Patients will be randomized to receive either a sham injection or the FAI
insert and will be observed for three years following treatment.


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

- At the time of enrollment (Day 1), 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

- During the 12 months prior to enrollment (Day 1), the study eye has either received
treatment:

- systemic corticosteroid or other systemic therapies given for at least 3 months,
and/or

- at least 2 intra- or peri-ocular administrations of corticosteroid for management
of uveitis

OR the study eye has experienced recurrence:

- at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular
injection of corticosteroid

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 structures

- 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 (10-21 mmHg)

- Intraocular pressure (IOP) > 21 mmHg or concurrent therapy at Screening with any
IOP-lowering pharmacologic 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 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 have tested positive for human immune deficiency virus (HIV),
tuberculosis or syphilis

- 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
We found this trial at
17
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Arlington, Texas 76012
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Beverly Hills, California
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Cambridge, Massachusetts
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303 East Superior Street
Chicago, Illinois 60611
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Colorado Springs, Colorado
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Durham, North Carolina 27710
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Houston, Texas 77030
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Houston, TX
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Ladson, South Carolina 29456
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Lexington, Kentucky
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Munster,
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Portland, Oregon
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Sacramento, California 95819
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San Antonio, Texas
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San Antonio, TX
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SLingerlands, New York 12159
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SLingerlands, NY
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Torrance, California 90503
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