Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00167518




Registration number
NCT00167518
Ethics application status
Date submitted
5/09/2005
Date registered
14/09/2005
Date last updated
14/09/2005

Titles & IDs
Public title
Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)
Scientific title
Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment
Secondary ID [1] 0 0
ORIA Esme Anderson Grant
Secondary ID [2] 0 0
JDRF 1-2003-767
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
• 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
Timepoint [1] 0 0
Primary outcome [2] 0 0
• Incidence of moderate or severe adverse effects related to treatment
Timepoint [2] 0 0
Secondary outcome [1] 0 0
• Any change of visual acuity (treated versus untreated eyes) at 3 months and 24 months after treatment
Timepoint [1] 0 0
Secondary outcome [2] 0 0
• 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.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
• Changes in semi-quantitative grading of cataract at 3 months and 24 months.
Timepoint [3] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark C Gillies, MBBS, PhD
Address 0 0
Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT00167518