NCT00543296

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2004

Typical duration for phase_4

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

March 1, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

July 9, 2014

Completed
Last Updated

March 31, 2015

Status Verified

June 1, 2014

Enrollment Period

3.3 years

First QC Date

October 11, 2007

Results QC Date

August 8, 2013

Last Update Submit

March 12, 2015

Conditions

Uveitis

Keywords

uveitisCystoid Macular Edema (CME)fluocinolone acetonidenon-infectious uveitis affecting the posterior segment

Outcome Measures

Primary Outcomes (1)

  • Number of Eyes With Inflammation Recurrence

    Number of eyes with inflammation recurrence

    5 years

Secondary Outcomes (3)

  • Percentage of Eyes With Improvement in Visual Acuity

    baseline to 52 weeks

  • Number of Participant's Eye Requiring Adjunctive Therapy

    5 years

  • Number of Eyes With Increased Intraocular Pressure

    52 weeks

Study Arms (1)

0.59 mg Fluocinolone Acetonide implant

EXPERIMENTAL

0.59 mg Fluocinolone Acetonide implant

Drug: 0.59 mg Fluocinolone Acetonide implant

Interventions

0.59 mg Fluocinolone Acetonide implantDRUG

0.59 mg Fluocinolone Acetonide implant

Also known as: Retisert
0.59 mg Fluocinolone Acetonide implant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Infectious uveitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

UveitisMacular Edema

Interventions

Fluocinolone Acetonide

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesMacular DegenerationRetinal DegenerationRetinal Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Glenn J. Jaffe, MD
Organization
Duke University Medical Center
jaffe001@mc.duke.edu
919-684-4458

Study Officials

  • Glenn J Jaffe, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2007

First Posted

October 12, 2007

Study Start

March 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

March 31, 2015

Results First Posted

July 9, 2014

Record last verified: 2014-06

Locations

US(1)