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

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543296
• Other study ID #: Pro00013641
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2007
• Last updated: March 12, 2015
• Start date: March 2004
• Est. completion date: July 2007

Study information

• Verified date: June 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• 0.59 mg Fluocinolone Acetonide implant
0.59 mg Fluocinolone Acetonide implant

Locations

Country	Name	City	State
United States	Duke University Eye Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Eyes With Inflammation Recurrence	Number of eyes with inflammation recurrence	5 years	Yes
Secondary	Percentage of Eyes With Improvement in Visual Acuity	Visual acuity was improved by two or more lines from baseline.	baseline to 52 weeks	Yes
Secondary	Number of Participant's Eye Requiring Adjunctive Therapy	Adjunctive Therapy needed to control inflammation in the implanted eye	5 years	Yes
Secondary	Number of Eyes With Increased Intraocular Pressure		52 weeks	Yes