Status:
COMPLETED
Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)
Lead Sponsor:
University of Sydney
Conditions:
Diabetic Macular Oedema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 conv...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00167518
Start Date
March 1 2002
End Date
April 1 2005
Last Update
September 14 2005
Active Locations (1)
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1
Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney
Sydney, New South Wales, Australia, 2000