NCT00148330

Brief Summary

This open label extension will treat all the eyes of study participants with active study medication (intravitreal triamcinolone) as well as standard laser treatment where appropriate. The specific aims will be to test the following hypotheses:

  • That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment remains efficacious over five years
  • That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment retains a manageable and acceptable safety profile over five years

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 30, 2010

Status Verified

May 1, 2005

Enrollment Period

3.2 years

First QC Date

September 6, 2005

Last Update Submit

June 29, 2010

Conditions

Diabetic Macular Oedema

Keywords

Diabetic macular oedemaTriamcinolone acetateIntravitreal injectionClinical trialLaser treatment

Outcome Measures

Primary Outcomes (2)

  • Increase of ≥5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit.

    Changes from Baseline to 5 years: Improvement of ≥5 letters after 5 years was found in 14/33 (42%) eyes initially treated with triamcinolone compared with 11/34 (32%) eyes initially treated with placebo (zGEE=0.81, P=0.4). Changes from 2 to 5 years (open-label extension):Improvement of ≥5 letters of best-corrected visual acuity was found in 8/29 (28%) eyes initial-triamcinolone compared with 7/28 (25%) initial-placebo eyes (zGEE=0.20, P=0.8).

    3 year extension, total 5 years study from baseline

  • Incidence of moderate or severe adverse events over the 3 years of the open-label extension

    The incidence of cataract surgery declined in the third year: 5/11 (45%) eyes from the initial-triamcinolone group that were phakic at the beginning of the 3rd year required cataract surgery.

    3 year extension study, total 5 year study from baseline

Secondary Outcomes (3)

  • Change in macular thickness by OCT

    3 year extension, total 5 year study from the baseline

  • Any change in visual acuity

    3 year extension, total 5 year study from the baseline

  • Number of laser treatments required.

    3 year extension study, total 5 year study from baseline

Interventions

Triamcinolone acetateDRUG

When indicated, intravitreal triamcinolone (0.1 ml of Kenacort 40© \[40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia\]) was injected into the vitreous under sterile conditions in a minor procedures area.

Also known as: Kenacort 40©

Eligibility Criteria

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

You may qualify if:

  • Participation in the study will be offered to all patients at the conclusion of the TDMO study. Currently we are still following 64 of the 69 (93%) eyes that were initially entered into the study that had reduced vision from diabetic macular oedema at baseline.

You may not qualify if:

  • Uncontrolled glaucoma
  • Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration)
  • known allergies to triamcinolone acetate, patient is already receiving systemic steroid treatment, intercurrent severe disease such as septicemia, 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 (9)

  • 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: 15522370BACKGROUND

  • 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: 15860283BACKGROUND

  • Kuo CH, Gillies MC. Role of steroids in the treatment of diabetic macular edema. Int Ophthalmol Clin. 2009 Spring;49(2):121-34. doi: 10.1097/IIO.0b013e31819fcce8. No abstract available.

    PMID: 19349792BACKGROUND

  • Gillies MC, Simpson JM, Gaston C, Hunt G, Ali H, Zhu M, Sutter F. Five-year results of a randomized trial with open-label extension of triamcinolone acetonide for refractory diabetic macular edema. Ophthalmology. 2009 Nov;116(11):2182-7. doi: 10.1016/j.ophtha.2009.04.049. Epub 2009 Oct 1.

    PMID: 19796823RESULT

  • Gillies M. Diabetic macular edema. Ophthalmology. 2009 Mar;116(3):595; author reply 596-7. doi: 10.1016/j.ophtha.2008.12.016. No abstract available.

    PMID: 19264220RESULT

  • Gillies MC, Simpson JM, Zhu M, Hunt G, Ali H, Gaston C. Intravitreal triamcinolone. Ophthalmology. 2009 Mar;116(3):591. doi: 10.1016/j.ophtha.2008.09.044. No abstract available.

    PMID: 19264215RESULT

  • Gillies MC, Sutter FK, Simpson JM, Larsson J, Ali H, Zhu M. Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial. Ophthalmology. 2006 Sep;113(9):1533-8. doi: 10.1016/j.ophtha.2006.02.065. Epub 2006 Jul 7.

    PMID: 16828501RESULT

  • Larsson J, Kifley A, Zhu M, Wang JJ, Mitchell P, Sutter FK, Gillies MC. Rapid reduction of hard exudates in eyes with diabetic retinopathy after intravitreal triamcinolone: data from a randomized, placebo-controlled, clinical trial. Acta Ophthalmol. 2009 May;87(3):275-80. doi: 10.1111/j.1755-3768.2008.01245.x. Epub 2008 Sep 10.

    PMID: 18785964RESULT

  • Wickremasinghe SS, Rogers SL, Gillies MC, Zhu M, Wong TY. Retinal vascular caliber changes after intravitreal triamcinolone treatment for diabetic macular edema. Invest Ophthalmol Vis Sci. 2008 Nov;49(11):4707-11. doi: 10.1167/iovs.08-1678. Epub 2008 Jul 3.

    PMID: 18599569DERIVED

MeSH Terms

Interventions

TriamcinoloneTriamcinolone Acetonide

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

May 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 30, 2010

Record last verified: 2005-05

Locations

AU(1)