Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: University of Sydney
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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)