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Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study

NCT00148330 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2010-06-30

No results posted yet for this study

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 aims will be to test the following hypotheses:

* That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment remains efficacious over five years
* That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment retains a manageable and acceptable safety profile over five years

Conditions

  • Diabetic Macular Oedema

Interventions

DRUG

Triamcinolone acetate

When indicated, intravitreal triamcinolone (0.1 ml of Kenacort 40© \[40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia\]) was injected into the vitreous under sterile conditions in a minor procedures area.

Sponsors & Collaborators

  • University of Sydney

    lead OTHER

Principal Investigators

  • Mark C Gillies, MBBS, PhD · Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00148330 on ClinicalTrials.gov