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

This study has been completed.
Sponsor:
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00167518
First received: September 5, 2005
Last updated: September 11, 2005
Last verified: January 2005
  Purpose

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 Intervention Phase
Diabetic Macular Oedema
Drug: Triamcinolone acetate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • • 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 Outcome Measures:
  • • 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.

Estimated Enrollment: 70
Study Start Date: March 2002
Estimated Study Completion Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167518

Locations
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
Investigators
Principal Investigator: Mark C Gillies, MBBS, PhD Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00167518     History of Changes
Other Study ID Numbers: JDRF 1-2003-767, ORIA Esme Anderson Grant, Sydney Eye Hospital Foundation
Study First Received: September 5, 2005
Last Updated: September 11, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Sydney:
Diabetic macular oedema
Triamcinolone acetate
Intravitreal injection
Clinical trial
Laser treatment

Additional relevant MeSH terms:
Edema
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014