NCT00344968

Brief Summary

This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
956

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2007

Typical duration for phase_3

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

First Submitted

Initial submission to the registry

June 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 7, 2014

Completed
Last Updated

May 7, 2014

Status Verified

April 1, 2014

Enrollment Period

2.3 years

First QC Date

June 26, 2006

Results QC Date

September 27, 2013

Last Update Submit

April 8, 2014

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).

    36 months

Secondary Outcomes (1)

  • Retinal Thickness

    36 months

Study Arms (3)

1

EXPERIMENTAL
Drug: fluocinolone acetonide

2

EXPERIMENTAL
Drug: Fluocinolone Acetonide

3

SHAM COMPARATOR
Procedure: Standard of care laser photocoagulation

Interventions

Fluocinolone AcetonideDRUG

0.5 mg fluocinolone acetonide intravitreal insert

1
Standard of care laser photocoagulationPROCEDURE

Laser photocoagulation

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years with diabetic macular edema
  • Diagnosis of diabetes mellitus types 1 or 2
  • Best corrected visual acuity of 19-68 letters
  • Retinal thickness \> 250 micron by OCT
  • Investigator is comfortable deferring macular laser treatment for 6 weeks

You may not qualify if:

  • Glaucoma, ocular hypertension, IOP \>21 mmHg or concurrent therapy at screening with IOP lowering agents
  • Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
  • Prior intravitreal, subtenon, or periocular steroid therapy within 6 months
  • Any ocular surgery within the last 3 months
  • Retinal laser treatment within the last 3 months
  • History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
  • Any lens opacity which impairs visualization of the posterior pole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Atlanta, Georgia, United States

Location

Related Publications (2)

  • Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.

    PMID: 33206392DERIVED

  • Holden SE, Kapik B, Beiderbeck AB, Currie CJ. Comparison of data characterizing the clinical effectiveness of the fluocinolone intravitreal implant (ILUVIEN) in patients with diabetic macular edema from the real world, non-interventional ICE-UK study and the FAME randomized controlled trials. Curr Med Res Opin. 2019 Jul;35(7):1165-1176. doi: 10.1080/03007995.2018.1560779. Epub 2019 Jan 17.

    PMID: 30569759DERIVED

MeSH Terms

Interventions

Fluocinolone Acetonide

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Kathleen Billman, Senior Director of Scientific Affairs
Organization
Alimera Sciences, Inc.
kathleen.billman@alimerasciences.com
678-572-1302

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2006

First Posted

June 27, 2006

Study Start

September 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

May 7, 2014

Results First Posted

May 7, 2014

Record last verified: 2014-04

Locations

US(1)