A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is likely to identify an improved and economical treatment for diabetic macular oedema, one of the commonest causes of blindness both in Australia and the rest of the world.The specific aims of the study are to test the following hypotheses:

• That intravitreal triamcinolone followed by laser treatment results in a greater improvement in visual acuity than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes;

• That intravitreal triamcinolone followed by laser treatment results in greater degree of resolution of macular oedema than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes;

• That intravitreal triamcinolone followed by laser treatment results in a reduced requirement for further laser treatment to control diabetic macular oedema than placebo followed by laser treatment;

• That intravitreal triamcinolone followed laser has a manageable and acceptable safety profile in eyes with diabetic macular edema.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sydney
• Collaborators: Marsden Eye Centre; Marsden Eye Specialists; The University of Western Australia; University of Melbourne
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Age >= 18 years

• Diagnosis of diabetes mellitus types 1 or 2

• Diabetic macular oedema affecting the fovea in one or both eyes (phakic or pseudophakic) for which laser treatment is indicated in the opinion of the investigator

• Best corrected visual acuity of 19-68 letters (6/12 -6/120)

• Definite macular oedema on clinical examination involving the centre of the macula

• Retinal thickness > 250 micron in central 1mm subfield on OCT

• Investigator is comfortable deferring macular laser treatment for 6 weeks

Exclusion Criteria:

• Glaucoma which is uncontrolled or is controlled but with glaucomatous field defects

• Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion)

• Macular oedema due to other causes including vitreous traction

• An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy)

• Previous treatment IVTA within 6 months or with peribulbar TA within 3 months

• Cataract surgery within the last 6 months

• Retinal laser treatment within the last 4 months

• High risk PDR at baseline or laser therapy cannot be delayed for 6 weeks on retina

• History of herpes viral disease in study eye

• Media opacity including cataract that already precludes adequate macular photography and laser treatment, or cataract that is likely to preclude an adequate view within 2 years

• Known allergies to triamcinolone acetate

• Patient is already receiving systemic steroid treatment

• Intercurrent severe disease such as septicemia, any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social)

• History of chronic renal failure requiring dialysis or renal transplant

• Blood pressure >180/110 mmHg