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Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01694186
Recruitment Status : Active, not recruiting
First Posted : September 27, 2012
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
pSivida Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Posterior Uveitis Intermediate Uveitis Panuveitis Drug: FAI insert Drug: Sham injection Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : October 10, 2016
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Sham Comparator: sham injection
sham injection
Drug: Sham injection
Experimental: FAI insert
FAI insert (0.18 mg fluocinolone acetonide)
Drug: FAI insert

Primary Outcome Measures :
  1. Recurrence of uveitis in study eye [ Time Frame: one year ]

Secondary Outcome Measures :
  1. recurrence of uveitis in the study eye [ Time Frame: three years ]

Other Outcome Measures:
  1. recurrence of uveitis in the fellow eye [ Time Frame: one year ]
  2. recurrence of uveitis in the fellow eye [ Time Frame: three years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01694186

  Hide Study Locations
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United States, California
Retina Vitreaous Associates
Beverly Hills, California, United States
Retinal Consultants Medical Group, Inc
Sacramento, California, United States
Retina Macula Institute
Torrance, California, United States
United States, Colorado
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
United States, Illinois
Northwestern University
Chicago, Illinois, United States
United States, Kentucky
Ophthalmology & Visual Sciences
Lexington, Kentucky, United States
United States, Massachusetts
Ocular Immunology and Uveitis Foundation
Cambridge, Massachusetts, United States
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States
United States, New York
Retina Consultants
Slingerlands, New York, United States
United States, North Carolina
Duke University Eye Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States
United States, Oregon
OHSU Casey Eye Institute
Portland, Oregon, United States
United States, South Carolina
Charleston Neuroscience Institute
Ladson, South Carolina, United States, 29456
United States, Texas
Texas Retina Associates
Arlington, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Foresight Studies, LLC
San Antonio, Texas, United States
Augenarzte am St. Franziskus Hospital
Munster, Germany
Universitatsklinikum Tubingen
Tubingen, Germany
Bajcsy-Zsilinszky Kórház és Rendelőintézet
Budapest, Hungary
L. V. Prasad Eye Institute - Hospital
Hyderabad, Andhra Pradesh, India
L.V. Prasad Eye Institute
Patia, Bhubaneshwar, India
C.H Nagri Municipal Eye Hospital
Ahmedabad, Gujarat, India
Seth G.S. Medical College & KEM Hospital
Parel, Mumbai, India
PBMA'S H.V. Desai Eye Hospital
Hadapsar, Pune, India
King George's Medical University
Lucknow, Uttar Pradesh, India
Hadassah University Hospital Ein Kerem
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Qiryat Ono, Israel
United Kingdom
Royal Hospitals Trust
Belfast, United Kingdom
Birmingham and Midland Eye Centre
Birmingham, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Gloucestershire Royal Hospital
Gloucester, United Kingdom
Moorfields Eye Hospital
London, United Kingdom
St Thomas Hospital
London, United Kingdom
Sponsors and Collaborators
pSivida Corp.
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Principal Investigator: Glenn Jaffe, MD Duke University Eye Center

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Responsible Party: pSivida Corp. Identifier: NCT01694186     History of Changes
Other Study ID Numbers: PSV-FAI-001
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Choroid Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs