Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

NCT00456482 | Terminated Phase 2 DMC

• 1 other identifier: 415-004
• Study Type: interventional
• Target: 239
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide 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.

Conditions

Non-infectious Uveitis

Outcome Measures

Primary Outcomes (1)

• Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye.

  1 year pre-implantation; 3 years post-implantation

Secondary Outcomes (1)

• Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys.

  1 year pre-implantation; 3 years post-implantation

Study Arms (3)

Fluocinolone Acetonide 0.59mg

EXPERIMENTAL

Fluocinolone acetonide intravitreal implant 0.59mg

Drug: Fluocinolone Acetonide 0.59mg

Fluocinolone Acetonide 2.1mg

EXPERIMENTAL

Fluocinolone acetonide intravitreal implant 2.1mg

Drug: Fluocinolone Acetonide 2.1mg

No Intervention

NO INTERVENTION

Fellow eye

Interventions

Fluocinolone Acetonide 0.59mg DRUG

Fluocinolone Acetonide Intravitreal Implant 0.59 mg

Fluocinolone Acetonide 0.59mg

Fluocinolone Acetonide 2.1mg DRUG

Fluocinolone Acetonide Intravitreal Implant 2.1 mg

Fluocinolone Acetonide 2.1mg

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Had clinically 'quiet' eyes at surgery.

You may not qualify if:

• Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Related Publications (1)

• Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.

  PMID: 16690128 BACKGROUND

MeSH Terms

Interventions

Fluocinolone Acetonide

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Timothy L Comstock, OD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 5, 2007
• Study Start: May 1, 2002
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: December 8, 2011

Record last verified: 2011-12