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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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. Initially, this was a 2-dose randomized pilot study. However, the study was modified to include only the 0.2 ug/day implant.

Detailed Summary:
Sponsor: Glenn Jaffe

Current Primary Outcome: 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. ]

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).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]
    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. ]
    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. ]
    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. ]
    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. ]
    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. ]
    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. ]
    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).


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: December 4, 2012
Date Started: June 2012
Date Completion: December 2018
Last Updated: April 27, 2017
Last Verified: April 2017