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CompletedNCT00570830Updated Sep 3, 2014

Retisert and Cataract Surgery in Patients With Severe Uveitis

An interventional study of Retisert (fluocinolone acetonide implant) in Intermediate Uveitis and Posterior Uveitis, sponsored by Duke University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2014-09-03.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Sex
All
01

Study summary

To review chart data at the Duke Eye Center and determined whether a 3-year fluocinolone acetonide sustained drug delivery system (FA) safely suppressed postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis.

Read the detailed description

Cataracts are common in eyes with uveitis. It results from inflammation or the use of topical or systemic steroids. Cataract surgery can cause an unusually severe inflammatory response, abnormal or excessive bleeding, and unexpected postoperative IOP responses such as hypertension or hypotony. Previous studies showed that successful outcome is preoperative and postoperative control of intraocular inflammation by topical, periocular, and systemic steroidal or immunosuppressive agents. In patients with severe posterior uveitis, periocular and intravitreal injections often provide only transient effects and are associated with complications such as hemorrhage, retinal detachment and endophthalmitis. Oral corticosteroid therapy are also associated with side effects to multiple organ systems in the body. A novel technology that delivers corticosteroid therapy linearly via an intravitreal, polymer-coated, sustained release implant has been developed and FDA approved to treat severe posterior segment uveitis. FA implantation effectively controls inflammation over an extended period of time in a complicated group of patients with posterior and/or panuveitis and allows reduced immunosuppression. We hope to determined whether this implant, a fluocinolone acetonide sustained drug delivery system (FA), can safely suppress postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis. We hypothesize that combining the implant with cataract surgery will provide better surgical outcomes by suppressing inflammation during the postoperative period. By reviewing our own surgical data at the Duke Eye Center, we intend to primarily focus on the safety and effectiveness of this surgical procedure.

02

Conditions studied

  • Intermediate Uveitis
  • Posterior Uveitis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • A visually significant cataract
  • A history of recurrent noninfectious posterior uveitis or intermediate uveitis with or without iridocyclitis
  • incomplete therapeutic response or treatment-limiting side effects to oral, periocular corticosteroid, and/or immunosuppressive agents
  • VA of at least light perception; and
  • Ability to comprehend informed consent and comply with follow-up examinations

Exclusion criteria

Exclusion Criteria:

  • An allergy to fluocinolone acetonide or any component of the delivery system
  • A toxoplasmosis scar was present in the study eye,
  • A peripheral retinal detachment (RD) in the area of the planned fluocinolone acetonide implant placement
  • Required chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to treat non-ocular disease or if they tested positive for human immunodeficiency virus.
  • Also excluded were female patients who were pregnant or lactating or not taking precautions to avoid pregnancy.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Other
    1

    single armed case series in which all patients underwent the same treatment.

    Device: Retisert (fluocinolone acetonide implant)

Interventions

  • DeviceRetisert (fluocinolone acetonide implant)

    Patients with intermediate, posterior or pan-uveitis underwent simultaneous fluocinolone acetonide implantation (0.59 mg or 2.1 mg) and phacoemulsification and intraocular lens.

    Also known as: 1

05

What researchers measure

Primary outcomes

  1. Preoperative and postoperative ocular inflammation

    Time frame: up to 12 months postoperatively

Secondary outcomes

  1. visual acuity

    Time frame: up to 12 months postoperatively

06

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 07710, United States
07

References and documents

Publications

  • Foster CS, Fong LP, Singh G. Cataract surgery and intraocular lens implantation in patients with uveitis. Ophthalmology. 1989 Mar;96(3):281-8. doi: 10.1016/s0161-6420(89)32898-3. PubMed 2629713 ↗
  • Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9. PubMed 16690128 ↗
  • Chieh JJ, Carlson AN, Jaffe GJ. Combined fluocinolone acetonide intraocular delivery system insertion, phacoemulsification, and intraocular lens implantation for severe uveitis. Am J Ophthalmol. 2008 Oct;146(4):589-594. doi: 10.1016/j.ajo.2008.05.035. Epub 2008 Jul 17. PubMed 18639220 ↗
08

Registry details

Key details

Study ID
NCT00570830
Lead sponsor
Duke University
First posted
Dec 11, 2007
Start date
Sep 2006
Primary completion
Nov 2007
Completion
May 2008
Last update
Sep 3, 2014

Study contacts

Glenn J Jaffe, MD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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