At a glance
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An Open Label Extension of the Phase II/III Clinical Trial of Intravitreal Triamcinolone on the Effects and Safety of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment
In Brief
A Phase 3 clinical trial evaluating Triamcinolone acetate for Diabetic Macular Oedema. Completed, enrolled 64 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
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.