Retisert and Cataract Surgery in Patients With Severe Uveitis

This study has been completed.
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00570830
First received: December 10, 2007
Last updated: August 13, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Intermediate Uveitis
Posterior Uveitis
Device: Retisert (fluocinolone acetonide implant)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Fluocinolone Acetonide Sustained Drug Delivery System Implantation and Phacoemulsification/Intraocular Lens Implantation in Patients With Severe Uveitis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Preoperative and postoperative ocular inflammation [ Time Frame: up to 12 months postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • visual acuity [ Time Frame: up to 12 months postoperatively ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: September 2006
Study Completion Date: May 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
single armed case series in which all patients underwent the same treatment.
Device: Retisert (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.
Other Name: 1

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.

  Eligibility

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

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:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570830

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 07710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Glenn J Jaffe, MD Duke University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Glenn J Jaffe, MD, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00570830     History of Changes
Other Study ID Numbers: 9145-06--10R0ER
Study First Received: December 10, 2007
Last Updated: August 13, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveitis, Intermediate
Pars Planitis
Uveitis, Posterior
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Panuveitis
Fluocinolone Acetonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014