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Completed

NCT Number: NCT00407082

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.

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Key information

Conditions

Noninfectious Posterior Uveitis

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Duke Eye Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent, non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study, and had 'quiet' eyes at surgery

Exclusion criteria

  • Coexisting medical or ocular conditions that would interfere with the study results

Treatment and study plan

fluocinolone acetonide intravitreal implant

Drug

Fluocinolone acetonide ocular implant 0.59mg

Fluocinolone acetonide 2.1mg

Drug

Fluocinolone acetonide ocular implant 2.1mg

Primary outcomes

  1. Recurrence of uveitis before and after implantation.

    Time frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation

Secondary outcomes

  1. Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes.

    Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation

  2. Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes.

    Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation

  3. The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation)

    Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation

  4. Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes)

    Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation

  5. Results of QOL surveys pre- versus post-implantation

    Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation

  6. Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes)

    Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation

  7. Time to recurrence, between treatment group comparison

    Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation

  8. Post implantation uveitis rate, between treatment group comparison

    Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Dec 4, 2006
Registry last updated
Dec 8, 2011

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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