Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis
Overview
- Phase
- Phase 1
- Intervention
- Fluocinolone Acetonide
- Conditions
- Uveitis Affecting the Posterior Segment
- Sponsor
- Glenn Jaffe
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Change in status of uveitis in study eye.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Glenn Jaffe
Professor
Duke University
Eligibility Criteria
Inclusion Criteria
- •At least 18 years old at time of consent.
- •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) OR unable to tolerate the side effects of therapy with systemic corticosteroid or other equivalent non-steroidal immunosuppressive agent OR recurrence of uveitis after having received an FAi (Fluocinolone Acetonide intravitreal insert).
- •Negative serum pregnancy test at baseline for women of childbearing potential.
- •An informed consent document signed and dated by the subject or a legally acceptable representative.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
- •Subjects presenting with any of the following will not be included in the study:
- •History of glaucoma in the study eye
- •Allergy to corticosteroids of any component of delivery system
- •History of iridocyclitis only and no vitreous cells or vitreous haze in the study eye
- •Uveitis with infectious etiology in the study eye
- •Vitreous hemorrhage in the study eye
- •Toxoplasmosis scar in study eye
- •Media opacity precluding evaluation of retina and vitreous in the study eye
- •Peripheral retinal detachment in area of insertion in the study eye
- •Elevated Intraocular pressure (IOP) \>21 on no more than 1 anti-ocular hypertensive medication in the study eye
Arms & Interventions
Low dose FA-i (Fluocinolone Acetonide insert)
Each FA-i contains 180 µg FA (Fluocinolone Acetonide) designed to be released over 15 - 30 months.
Intervention: Fluocinolone Acetonide
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change in lens status in study eye.(Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.)
- Change in retinal status in study eye.(Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.)
- Change in macular thickness in study eye.(Assessed at Screening, Day 14, 28, Months 2, 3, 6, 9, 12, 15, 18, 21, and 24.)
- Change in Best Corrected Visual Acuity in the study eye.(Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.)
- Change in IOP (intraocular pressure) in study eye.(Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.)
- Change in vitreous status in study eye.(Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.)
- Change in endophthalmitis in study eye.(Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.)