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Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis (Iluvien)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Glenn Jaffe, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01781936
First received: December 4, 2012
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine the tolerability, safety, and benefits of an investigational drug,Fluocinolone Acetonide Intravitreal Insert (FA-i), in people who have posterior uveitis. The study drug, Fluocinolone Acetonide, is currently used in a surgical implant, Retisert, which is approved by the U.S. Food and Drug Administration (FDA) to treat non-infectious posterior uveitis . The study drug is able to be inserted in an ophthalmology (eye)clinic whereas Retisert must be surgically implanted in the Operating Room. Two doses of fluocinolone acetonide will be used in this study to determine if either strength of fluocinolone acetonide can effectively treat uveitis and if so, which strength works better. Or, it is possible that both strengths may work about the same but one strength may have fewer side effects.


Condition Intervention Phase
Uveitis Affecting the Posterior Segment.
Drug: Fluocinolone Acetonide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in status of uveitis in study eye. [ Time Frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24. ] [ Designated as safety issue: Yes ]

    Anterior chamber cells will be measured using a Haag-Streit Slit Lamp at high magnification (1.6 X) x 1mm beam. Assessment will be made using the Standardization of Uveitis Nomenclature (SUN) scale.

    Ophthalmoscopy will be performed to assess vitreous haze, which will be graded according to the scale provided with photographs reproduced from Nussenblatt et al, (Ophthalmology 92:467-471, 1985).



Secondary Outcome Measures:
  • Change in IOP (intraocular pressure) in study eye. [ Time Frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24. ] [ Designated as safety issue: Yes ]
    Goldmann tonometry will be used to measure IOP.

  • Change in lens status in study eye. [ Time Frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24. ] [ Designated as safety issue: Yes ]
    Lens changes will be assessed with a Haag-Streit Slit Lamp.

  • Change in endophthalmitis in study eye. [ Time Frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24. ] [ Designated as safety issue: Yes ]
    The study eye will be evaluated for endophthalmitis by undergoing inspection with a Haag Streit Slit Lamp and an indirect ophthalmoscope.

  • Change in vitreous status in study eye. [ Time Frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24. ] [ Designated as safety issue: Yes ]
    A Haag-Streit Slit Lamp and an indirect ophthalmoscope will be used to assess for any hemorrhaging in the study eye.

  • Change in retinal status in study eye. [ Time Frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24. ] [ Designated as safety issue: Yes ]
    The retina will be evaluated using a Haag Streit Slit Lamp and an indirect ophthalmoscope.

  • Change in macular thickness in study eye. [ Time Frame: Assessed at Screening, Day 14, 28, Months 2, 3, 6, 9, 12, 15, 18, 21, and 24. ] [ Designated as safety issue: Yes ]
    Spectralis SD-OCT will be used to assess macular thickness.

  • Change in Best Corrected Visual Acuity in the study eye. [ Time Frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24. ] [ Designated as safety issue: Yes ]
    The visual acuity is measured according to the standard procedure developed for the Early Treatment Diabetic Retinopathy Study (ETDRS) and adapted for the Age-Related Eye Disease Study (AREDS).


Estimated Enrollment: 6
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High dose FA-i (Fluocinolone Acetonide insert)
Each FA-i contains 180 µg FA (Fluocinolone Acetonide)designed to be released over 15 - 30 months.
Drug: Fluocinolone Acetonide
Active Comparator: Low dose FA-i (Fluocinolone Acetonide insert)
Each FA-i contains 180 µg FA (Fluocinolone Acetonide) designed to be released over 15 - 30 months.
Drug: Fluocinolone Acetonide

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years old at time of consent.
  2. One or both eyes with a minimum of 1 year history of recurrent non-infectious uveitis affecting the posterior segment requiring either a) systemic corticosteroid or other equivalent non-steroidal immunosuppressive agent given for at least 3 months prior to enrollment OR at least 2 sub-Tenon's injections of corticosteroid for management of uveitis during 6 months prior to enrollment OR at least 2 separate recurrences of uveitis within 6 months prior to enrollment requiring systemic, intravitreal or sub-Tenon's injection of corticosteroid OR recurrence of uveitis after having received an intravitreal steroid implant (Ozurdex or Retisert).
  3. Negative serum pregnancy test at baseline for women of childbearing potential.
  4. An informed consent document signed and dated by the subject or a legally acceptable representative.
  5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  6. Unable to tolerate the side effects of therapy with systemic corticosteroid or other equivalent non-steroidal immunosuppressive agent

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  1. History of glaucoma in the study eye
  2. Allergy to corticosteroids of any component of delivery system
  3. History of iridocyclitis only and no vitreous cells or vitreous haze in the study eye
  4. Uveitis with infectious etiology in the study eye
  5. Vitreous hemorrhage in the study eye
  6. Toxoplasmosis scar in study eye
  7. Media opacity precluding evaluation of retina and vitreous in the study eye
  8. Peripheral retinal detachment in area of insertion in the study eye
  9. Elevated Intraocular pressure (IOP) >21 on no more than 1 anti-ocular hypertensive medication in the study eye
  10. Presence of history of elevated IOP (Intraocular Pressure)(above 22 mmHg) in the study eye while on corticosteroids unless the subject has previously undergone filtration surgery (tube shunt or trabeculectomy) following the episode of steroid-associated ocular hypertension. In the latter case, the subject will be eligible for enrollment, provided that the intraocular pressure is controlled at < 21 mmHg off anti-ocular hypertensive medications, provided that other enrollment criteria are met.
  11. Ocular surgery in the study eye within 3 months prior to enrollment requiring chronic systemic therapy
  12. Systemic immunosuppressive therapy to manage non-ocular disease
  13. Patients who have tested positive for human immune deficiency virus
  14. Pregnant females
  15. Patients for whom any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study
  16. Patients who are unlikely to comply with the study protocol
  17. 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 patient inappropriate for entry into this study.
  18. Treatment with an investigational drug or device in the study eye within 30 days preceding the device placement.
  19. 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 the first dose of study medication and throughout the study.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781936

Locations
United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Glenn Jaffe
Investigators
Principal Investigator: Glenn J. Jaffe, MD Duke University Eye Center
  More Information

No publications provided

Responsible Party: Glenn Jaffe, Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01781936     History of Changes
Other Study ID Numbers: Pro00033019
Study First Received: December 4, 2012
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Panuveitis
Eye Diseases
Uveal Diseases
Uveitis
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014