CompletedPhase 2Phase 3ACTRN12605000211662

Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema that Persists after Laser Treatment (TDMO)

Intravitreal triamcinolone injection for treatment of clinically significant diabetic macular oedema that persists after laser treatment


Sponsor

Professor Mark Gillies

Enrollment

70 participants

Start Date

Mar 1, 2002

Study Type

Interventional

Conditions

Summary

The trial completed in May 2005. A open lable clinical trial (TDMX) is an extension of this study.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema that Persists after Laser Treatment (TDMO). Participation likely involves follow-up visits.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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. Macular oedema i

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. 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 fovea. This treatment does not, however, always work and is inherently destructive. This study is 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. Study treatment with intravitreal triamcinolone or placebo will be administered within one week of the baseline angiogram and OCT and on the day of the baseline visual acuity measurement. Triamcinolone (0.1 ml Kenacort 40, 40mg/ml triamcinolone acetate, Bristol-Myers Squibb pharmaceuticals, Australia) will be injected into the vitreous. If there is still oedema present, laser treatment will be performed after 4 weeks from the triamcinolone treatment. The duration of the study is 2 years.


Locations(1)

Australia

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