Status:
COMPLETED
Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study
Lead Sponsor:
University of Sydney
Conditions:
Diabetic Macular Oedema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 a...
Detailed Description
A 25 fold increase in the risk of going blind on diagnosis of diabetes is one of the most daunting threats that patients face. People using insulin are particularly challenged because they are unable ...
Eligibility Criteria
Inclusion
- Participation in the study will be offered to all patients at the conclusion of the TDMO study. Currently we are still following 64 of the 69 (93%) eyes that were initially entered into the study that had reduced vision from diabetic macular oedema at baseline.
Exclusion
- Uncontrolled glaucoma
- Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration)
- 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, media opacities)
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00148330
Start Date
May 1 2005
End Date
July 1 2008
Last Update
June 30 2010
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