None listed
Conditions
Brief summary
The trial completed in May 2005. A open lable clinical trial (TDMX) is an extension of this study.
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 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
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.
Sponsors
Professor Mark Gillies
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
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).
Outcome results
None listed