NCT00167518

Brief Summary

The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe and efficacious for patients with clinically significant diabetic macular oedema that is recalcitrant to conventional laser therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2002

Typical duration 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

March 1, 2002

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

September 14, 2005

Status Verified

January 1, 2005

First QC Date

September 5, 2005

Last Update Submit

September 11, 2005

Conditions

Diabetic Macular Oedema

Keywords

Diabetic macular oedemaTriamcinolone acetateIntravitreal injectionClinical trialLaser treatment

Outcome Measures

Primary Outcomes (2)

  • • Proportion of treated versus untreated eyes with improvement of visual acuity by 5 letters or more on the ETDRS chart at 24 months, no less than 3 months after the most recent treatment episode. An interim analysis of the primary and secondary outcome

  • • Incidence of moderate or severe adverse effects related to treatment

Secondary Outcomes (3)

  • • Any change of visual acuity (treated versus untreated eyes) at 3 months and 24 months after treatment

  • • Proportion of treated versus untreated eyes with reduction of macular thickness as demonstrated with OCT at 3 months and 24 months. Both absolute change and percentage change will be analysed.

  • • Changes in semi-quantitative grading of cataract at 3 months and 24 months.

Interventions

Triamcinolone acetateDRUG

Eligibility Criteria

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

You may qualify if:

  • Clinically significant diabetic macular oedema involving the fovea in one or both eyes (phakic and/or pseudophakic) which persists at least 3 months after adequate macular photocoagulation.
  • best corrected visual acuity in the affected eye(s) 6/9 or worse

You may not qualify if:

  • Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field defects
  • Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration)
  • Significant macular ischemia (FFA)
  • No useful vision in fellow eye
  • Known allergies to triamcinolone acetate or steroids
  • Patient is already under systemic treatment with \> 5mg prednisolone (or equivalent) daily.
  • Intercurrent severe disease such as septicaemia
  • Any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney

Sydney, New South Wales, 2000, Australia

Location

Related Publications (4)

  • Sutter FK, Simpson JM, Gillies MC. Intravitreal triamcinolone for diabetic macular edema that persists after laser treatment: three-month efficacy and safety results of a prospective, randomized, double-masked, placebo-controlled clinical trial. Ophthalmology. 2004 Nov;111(11):2044-9. doi: 10.1016/j.ophtha.2004.05.025.

    PMID: 15522370RESULT

  • Larsson J, Zhu M, Sutter F, Gillies MC. Relation between reduction of foveal thickness and visual acuity in diabetic macular edema treated with intravitreal triamcinolone. Am J Ophthalmol. 2005 May;139(5):802-6. doi: 10.1016/j.ajo.2004.12.054.

    PMID: 15860283RESULT

  • 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

  • O'Day RF, Barthelmes D, Zhu M, Wong TY, McAllister IL, Arnold JJ, Gillies MC. Intraocular pressure rise is predictive of vision improvement after intravitreal triamcinolone acetonide for diabetic macular oedema: a retrospective analysis of data from a randomised controlled trial. BMC Ophthalmol. 2014 Oct 21;14:123. doi: 10.1186/1471-2415-14-123.

    PMID: 25335434DERIVED

MeSH Terms

Interventions

Triamcinolone

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Mark C Gillies, MBBS, PhD

    Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2005

First Posted

September 14, 2005

Study Start

March 1, 2002

Study Completion

April 1, 2005

Last Updated

September 14, 2005

Record last verified: 2005-01

Locations

AU(1)