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Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment

Primary Purpose

Uveitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

0.59 mg Fluocinolone Acetonide implant

About this trial

This is an interventional treatment trial for Uveitis focused on measuring uveitis, Cystoid Macular Edema (CME), fluocinolone acetonide, non-infectious uveitis affecting the posterior segment

Eligibility Criteria

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

Inclusion Criteria:

Non-infectious intermediate, posterior or panuveitis
Previous placement of fluocinolone acetonide implant with initial uveitis quiescence and subsequent recurrence of inflammation once implant depleted of drug

Exclusion Criteria:

Infectious uveitis

Sites / Locations

Duke University Eye Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

0.59 mg Fluocinolone Acetonide implant

Arm Description

0.59 mg Fluocinolone Acetonide implant

Outcomes

Primary Outcome Measures

Number of Eyes With Inflammation Recurrence

Number of eyes with inflammation recurrence

Secondary Outcome Measures

Percentage of Eyes With Improvement in Visual Acuity

Visual acuity was improved by two or more lines from baseline.

Number of Participant's Eye Requiring Adjunctive Therapy

Adjunctive Therapy needed to control inflammation in the implanted eye

Number of Eyes With Increased Intraocular Pressure

Full Information

NCT ID

NCT00543296

First Posted

October 11, 2007

Last Updated

March 12, 2015

Sponsor

Duke University

Collaborators

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT00543296

Brief Title

Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment

Official Title

Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.

Detailed Description

Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant. Hypothesis: The RetisertTM will be a safe and effective method to manage patients with severe uveitis

6. Conditions and Keywords

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

Uveitis

Keywords

uveitis, Cystoid Macular Edema (CME), fluocinolone acetonide, non-infectious uveitis affecting the posterior segment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.59 mg Fluocinolone Acetonide implant

Arm Type

Experimental

Arm Description

0.59 mg Fluocinolone Acetonide implant

Intervention Type

Drug

Intervention Name(s)

0.59 mg Fluocinolone Acetonide implant

Other Intervention Name(s)

Retisert

Intervention Description

0.59 mg Fluocinolone Acetonide implant

Primary Outcome Measure Information:

Title

Number of Eyes With Inflammation Recurrence

Description

Number of eyes with inflammation recurrence

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Percentage of Eyes With Improvement in Visual Acuity

Description

Visual acuity was improved by two or more lines from baseline.

Time Frame

baseline to 52 weeks

Title

Number of Participant's Eye Requiring Adjunctive Therapy

Description

Adjunctive Therapy needed to control inflammation in the implanted eye

Time Frame

5 years

Title

Number of Eyes With Increased Intraocular Pressure

Time Frame

52 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Non-infectious intermediate, posterior or panuveitis Previous placement of fluocinolone acetonide implant with initial uveitis quiescence and subsequent recurrence of inflammation once implant depleted of drug Exclusion Criteria: Infectious uveitis

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 Eye Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment

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