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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00167518 |
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Date of registration:
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05/09/2005 |
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Primary sponsor: |
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Public title:
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Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)
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Scientific title:
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Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00167518 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Contacts
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Name:
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Mark C Gillies, MBBS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetic Macular Oedema
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Intervention(s)
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Drug: Triamcinolone acetate
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Primary Outcome(s)
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• Incidence of moderate or severe adverse effects related to treatment
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• Proportion of treated versus untreated eyes with improvement of visual acuity by 5 letters or more on the ETDRS chart at 24 months, no less than 3 months after the most recent treatment episode. An interim analysis of the primary and secondary outcome
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Secondary Outcome(s)
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• Any change of visual acuity (treated versus untreated eyes) at 3 months and 24 months after treatment
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• Changes in semi-quantitative grading of cataract at 3 months and 24 months.
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• Proportion of treated versus untreated eyes with reduction of macular thickness as demonstrated with OCT at 3 months and 24 months. Both absolute change and percentage change will be analysed.
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Secondary ID(s)
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JDRF 1-2003-767
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ORIA Esme Anderson Grant
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Sydney Eye Hospital Foundation
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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