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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Triamcinolone acetate

Treatment: Drugs: Triamcinolone acetate

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

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

- best corrected visual acuity in the affected eye(s) 6/9 or worse
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field

- 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)

- 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
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
Other design features
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
University of Sydney

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

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

Summary results
Other publications