search
Back to results

Retisert and Cataract Surgery in Patients With Severe Uveitis

Primary Purpose

Intermediate Uveitis, Posterior Uveitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retisert (fluocinolone acetonide implant)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermediate Uveitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

Preoperative and postoperative ocular inflammation

Secondary Outcome Measures

visual acuity

Full Information

First Posted
December 10, 2007
Last Updated
August 29, 2014
Sponsor
Duke University
search

1. Study Identification

Unique Protocol Identification Number
NCT00570830
Brief Title
Retisert and Cataract Surgery in Patients With Severe Uveitis
Official Title
Combined Fluocinolone Acetonide Sustained Drug Delivery System Implantation and Phacoemulsification/Intraocular Lens Implantation in Patients With Severe Uveitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermediate Uveitis, Posterior Uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
single armed case series in which all patients underwent the same treatment.
Intervention Type
Device
Intervention Name(s)
Retisert (fluocinolone acetonide implant)
Other Intervention Name(s)
1
Intervention Description
Patients with intermediate, posterior or pan-uveitis underwent simultaneous fluocinolone acetonide implantation (0.59 mg or 2.1 mg) and phacoemulsification and intraocular lens.
Primary Outcome Measure Information:
Title
Preoperative and postoperative ocular inflammation
Time Frame
up to 12 months postoperatively
Secondary Outcome Measure Information:
Title
visual acuity
Time Frame
up to 12 months postoperatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn J Jaffe, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
07710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2629713
Citation
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.
Results Reference
background
PubMed Identifier
16690128
Citation
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.
Results Reference
background
PubMed Identifier
18639220
Citation
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.
Results Reference
derived

Learn more about this trial

Retisert and Cataract Surgery in Patients With Severe Uveitis

We'll reach out to this number within 24 hrs