NCT00407082

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

4.8 years

First QC Date

December 1, 2006

Last Update Submit

December 7, 2011

Conditions

Noninfectious Posterior Uveitis

Outcome Measures

Primary Outcomes (1)

  • Recurrence of uveitis before and after implantation.

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

Secondary Outcomes (8)

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

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

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

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

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

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

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

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

  • Results of QOL surveys pre- versus post-implantation

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

  • +3 more secondary outcomes

Study Arms (3)

Fluocinolone acetonide 0.59mg

EXPERIMENTAL

Fluocinolone acetonide ocular implant 0.59mg

Drug: fluocinolone acetonide intravitreal implant

Fluocinolone acetonide 2.1mg

EXPERIMENTAL

Fluocinolone acetonide ocular implant 2.1mg

Drug: Fluocinolone acetonide 2.1mg

No intervention

NO INTERVENTION

Fellow eye

Interventions

fluocinolone acetonide intravitreal implantDRUG

Fluocinolone acetonide ocular implant 0.59mg

Fluocinolone acetonide 0.59mg
Fluocinolone acetonide 2.1mgDRUG

Fluocinolone acetonide ocular implant 2.1mg

Fluocinolone acetonide 2.1mg

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (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, and had 'quiet' eyes at surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • 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: 16690128RESULT

  • Callanan DG, Jaffe GJ, Martin DF, Pearson PA, Comstock TL. Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. Arch Ophthalmol. 2008 Sep;126(9):1191-201. doi: 10.1001/archopht.126.9.1191.

    PMID: 18779477DERIVED

MeSH Terms

Interventions

Fluocinolone Acetonide

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Thomas A Crescuillo

    Bausch & Lomb Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2006

First Posted

December 4, 2006

Study Start

December 1, 2000

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

December 8, 2011

Record last verified: 2011-12

Locations

US(1)