Diabetic Macular Oedema Clinical Trial
Official title:
Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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