Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
Query!
Scientific title
Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment
Query!
Secondary ID [1]
0
0
ORIA Esme Anderson Grant
Query!
Secondary ID [2]
0
0
JDRF 1-2003-767
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema
0
0
Query!
Condition category
Condition code
Eye
0
0
0
0
Query!
Diseases / disorders of the eye
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Triamcinolone acetate
Treatment: Drugs: Triamcinolone acetate
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
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
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Query!
Primary outcome [2]
0
0
• Incidence of moderate or severe adverse effects related to treatment
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Query!
Secondary outcome [1]
0
0
• Any change of visual acuity (treated versus untreated eyes) at 3 months and 24 months after treatment
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Query!
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.
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Query!
Secondary outcome [3]
0
0
• Changes in semi-quantitative grading of cataract at 3 months and 24 months.
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2/Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2002
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2000 - Sydney
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Sydney
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe
and efficacious for patients with clinically significant diabetic macular oedema that is
recalcitrant to conventional laser therapy
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00167518
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Mark C Gillies, MBBS, PhD
Query!
Address
0
0
Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00167518
Download to PDF