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Completed

NCT Number: NCT00543296

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

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.

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Key information

Conditions

Uveitis Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Uveal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Eye Center

Durham, North Carolina, 27710, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.59 mg Fluocinolone Acetonide implant

Drug

0.59 mg Fluocinolone Acetonide implant

Other names: Retisert

Primary outcomes

  1. Number of Eyes With Inflammation Recurrence

    Time frame: 5 years

    Number of eyes with inflammation recurrence

Secondary outcomes

  1. Percentage of Eyes With Improvement in Visual Acuity

    Time frame: baseline to 52 weeks

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

  2. Number of Participant's Eye Requiring Adjunctive Therapy

    Time frame: 5 years

    Adjunctive Therapy needed to control inflammation in the implanted eye

  3. Number of Eyes With Increased Intraocular Pressure

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Bausch & Lomb Incorporated

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Oct 12, 2007
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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