Retisert and Cataract Surgery in Patients With Severe Uveitis

August 29, 2014 updated by: Duke University

Combined Fluocinolone Acetonide Sustained Drug Delivery System Implantation and Phacoemulsification/Intraocular Lens Implantation in Patients With Severe Uveitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preoperative and postoperative ocular inflammation
Time Frame: up to 12 months postoperatively
up to 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
visual acuity
Time Frame: up to 12 months postoperatively
up to 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Glenn J Jaffe, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9145 (Other Identifier: CTEP)
  • 9145-06--10R0ER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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