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Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167518
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
Information provided by:
University of Sydney

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

Condition or disease Intervention/treatment Phase
Diabetic Macular Oedema Drug: Triamcinolone acetate Phase 2 Phase 3

Detailed Description:

Diabetic retinopathy is a common cause of severe loss of visual and the most common cause of legal blindness in individuals between the ages of 20 and 65 years in developed countries. Swelling of the central retina, or "macular oedema" is the commonest cause of visual loss in diabetic retinopathy.

Diabetic macular oedema is treated with laser coagulation to the macular area according to established guidelines which take into account the extent of the leak and its proximity to the centre of the macula, the "fovea". This treatment does not, however, always work and is inherently destructive.

Intravitreal injection of crystalline steroids has been proposed as a new modality to treat clinically significant diabetic macular oedema.

To determine by means of a prospective, double-masked, randomised, placebo-controlled trial to determine whether an intravitreal injection of triamcinolone three months or more after focal or grid laser photocoagulation for clinically significant diabetic macular oedema will improve the visual acuity of eligible eyes. OCT will be used in addition to visual acuity testing as an objective measurement of macular oedema.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment
Study Start Date : March 2002
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Primary Outcome Measures :
  1. • 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
  2. • Incidence of moderate or severe adverse effects related to treatment

Secondary Outcome Measures :
  1. • Any change of visual acuity (treated versus untreated eyes) at 3 months and 24 months after treatment
  2. • 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.
  3. • Changes in semi-quantitative grading of cataract at 3 months and 24 months.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00167518

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Australia, New South Wales
Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney
Sydney, New South Wales, Australia, 2000
Sponsors and Collaborators
University of Sydney
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Principal Investigator: Mark C Gillies, MBBS, PhD Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00167518    
Other Study ID Numbers: JDRF 1-2003-767
ORIA Esme Anderson Grant
Sydney Eye Hospital Foundation
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: January 2005
Keywords provided by University of Sydney:
Diabetic macular oedema
Triamcinolone acetate
Intravitreal injection
Clinical trial
Laser treatment
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs