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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Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney

Sydney, New South Wales, Australia, 2000