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A Controlled, Multi-center Study of 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

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ClinicalTrials.gov Identifier: NCT02748512
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
pSivida Corp.

Brief Summary:
A controlled, multi-center study to evaluate the utilization and safety of the MK II inserter and the safety of the Fluocinolone Acetonide Intravitreal (FAI) insert in subjects with non-infectious uveitis affecting the posterior segment of the eye.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2016
Actual Primary Completion Date : September 19, 2017
Actual Study Completion Date : December 22, 2017


Arm Intervention/treatment
Experimental: FAI insert
FAI insert (0.18 mg fluocinolone acetonide)
Drug: FAI insert



Primary Outcome Measures :
  1. Investigator reported ease of intravitreal administration [ Time Frame: Seven days ]


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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02748512


Locations
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United States, Colorado
Retina Consultants of Southern Colorado PC
Colorado Springs, Colorado, United States, 80909-1183
United States, Massachusetts
Ocular Immunology and Uveitis Foundation
Waltham, Massachusetts, United States, 02451
United States, South Carolina
Charleston Neuroscience Center
Ladson, South Carolina, United States, 29456
United States, Texas
Texas Retina Associates - Fort Worth
Arlington, Texas, United States, 76012
Sponsors and Collaborators
pSivida Corp.

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Responsible Party: pSivida Corp.
ClinicalTrials.gov Identifier: NCT02748512     History of Changes
Other Study ID Numbers: PSV-FAI-006
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Uveitis
Panuveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Choroiditis
Choroid Diseases