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

NCT01781936 | Completed Phase 1

• 1 other identifier: Pro00033019
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis Affecting the Posterior Segment

Outcome Measures

Primary Outcomes (1)

• Change in status of uveitis in study eye.

  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).

  Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.

Secondary Outcomes (7)

• 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 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 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.

• 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 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.

Study Arms (1)

Low dose FA-i (Fluocinolone Acetonide insert)

EXPERIMENTAL

Each FA-i contains 180 µg FA (Fluocinolone Acetonide) designed to be released over 15 - 30 months.

Drug: Fluocinolone Acetonide

Interventions

Fluocinolone Acetonide DRUG

Low dose FA-i (Fluocinolone Acetonide insert)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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 on no more than one anti-ocular hypertensive medication.
• Ocular surgery in the study eye within 3 months prior to enrollment requiring chronic systemic therapy
• Systemic immunosuppressive therapy to manage non-ocular disease
• Patients who have tested positive for human immune deficiency virus
• Pregnant females

Sponsors & Collaborators

• Glenn Jaffe: lead

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Fluocinolone Acetonide

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Glenn J. Jaffe, MD

  Duke University Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: February 1, 2013
• Study Start: June 1, 2012
• Primary Completion: June 13, 2018
• Study Completion: June 13, 2018
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

US (1)