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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.
 
ClinicalTrials.gov Identifier: NCT01694186
Recruitment Status : Active, not recruiting
First Posted : September 27, 2012
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
pSivida Corp.

Tracking Information
First Submitted Date  ICMJE September 24, 2012
First Posted Date  ICMJE September 27, 2012
Last Update Posted Date April 4, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date October 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
Recurrence of uveitis in study eye [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01694186 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
recurrence of uveitis in the study eye [ Time Frame: three years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 24, 2012)
  • recurrence of uveitis in the fellow eye [ Time Frame: one year ]
  • recurrence of uveitis in the fellow eye [ Time Frame: three years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Posterior Uveitis
  • Intermediate Uveitis
  • Panuveitis
Intervention  ICMJE
  • Drug: FAI insert
  • Drug: Sham injection
Study Arms  ICMJE
  • Sham Comparator: sham injection
    sham injection
    Intervention: Drug: Sham injection
  • Experimental: FAI insert
    FAI insert (0.18 mg fluocinolone acetonide)
    Intervention: Drug: FAI insert
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 10, 2015)
129
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2012)
120
Estimated Study Completion Date  ICMJE December 2018
Actual Primary Completion Date October 10, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Hungary,   India,   Israel,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01694186
Other Study ID Numbers  ICMJE PSV-FAI-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party pSivida Corp.
Study Sponsor  ICMJE pSivida Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Glenn Jaffe, MD Duke University Eye Center
PRS Account pSivida Corp.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP