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Trial registered on ANZCTR


Registration number
ACTRN12605000211662
Ethics application status
Approved
Date submitted
22/08/2005
Date registered
25/08/2005
Date last updated
29/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema that Persists after Laser Treatment (TDMO)
Scientific title
Intravitreal triamcinolone injection for treatment of clinically significant diabetic macular oedema that persists after laser treatment
Universal Trial Number (UTN)
Trial acronym
TDMO study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 294 0
Condition category
Condition code
Metabolic and Endocrine 330 330 0 0
Diabetes
Eye 331 331 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diabetic retinopathy is a common cause of severe loss of visual and the most common cause of legal blindness in individuals between the ages of 20 and 65 years in developed countries. Macular oedema is the commonest cause of visual loss in diabetic retinopathy. Diabetic macular oedema is treated with laser coagulation to the macular area according to established guidelines which take into account the extent of the leak and its proximity to the fovea. This treatment does not, however, always work and is inherently destructive.
This study is a prospective, double-masked, randomised, placebo-controlled trial to determine whether an intravitreal injection of triamcinolone three months or more after focal or grid laser photocoagulation for clinically significant diabetic macular oedema will improve the visual acuity of eligible eyes.
Study treatment with intravitreal triamcinolone or placebo will be administered within one week of the baseline angiogram and OCT and on the day of the baseline visual acuity measurement. Triamcinolone (0.1 ml Kenacort 40, 40mg/ml triamcinolone acetate, Bristol-Myers Squibb pharmaceuticals, Australia) will be injected into the vitreous.
If there is still oedema present, laser treatment will be performed after 4 weeks from the triamcinolone treatment.
The duration of the study is 2 years.
Intervention code [1] 224 0
Treatment: Drugs
Comparator / control treatment
Eyes randomized to receive placebo will be prepared the same way but only balanced salt solution will be administered subconjunctivally.
Control group
Placebo

Outcomes
Primary outcome [1] 387 0
Proportion of treated versus untreated eyes with improvement of visual acuity by 5 letters or more on the ETDRS chart
Timepoint [1] 387 0
At 24 months, no less than 3 months after the most recent treatment episode.

An interim analysis of the primary and secondary outcomes will be performed on data collected at the 3 month study visit.
Primary outcome [2] 388 0
Incidence of moderate or severe adverse effects related to treatment
Timepoint [2] 388 0
An interim analysis of the primary and secondary outcomes will be performed on data collected at the 3 month study visit.
Secondary outcome [1] 854 0
Any change of visual acuity (treated versus untreated eyes).
Timepoint [1] 854 0
At 3 months and 24 months after treatment.
Secondary outcome [2] 855 0
Proportion of treated versus untreated eyes with reduction of macular thickness as demonstrated with OCT
Timepoint [2] 855 0
At 3 months and 24 months.
Secondary outcome [3] 856 0
Both absolute change and percentage change will be analysed. Comparisons between treatment groups will include mean change as well as proportion with absolute decreases of > 75µm, > 100µm and > 200µm and percentage decreases of > 25%, > 50%, and > 75%. Changes in semi-quantitative grading of cataract
Timepoint [3] 856 0
At 3 months and 24 months.

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
Not stated
Maximum age
Not stated
Gender
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)
When the ophthalmologist is satisfied that the patient understands the study design and is willing to enter the study the patient is asked to sign the informed consent form. A randomized schedule has been generated using computer generated pseudo random numbers with variable block sizes. Treatment assignments are kept as a series of numbered opaque envelopes stored in a locked filing cabinet in the clinic. The identification of patients will consist of a code made up of the patient’s initials and number. Observers assessing best corrected visual acuity will be masked to treatment allocation, as well the investigator who performs laser treatment and decides whether further treatment is indicated or not. The surgeon performing the injections will be unmasked to treatment allocation. The photographer and OCT operators need not be masked.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were randomized to receive study treatment using a series of serially numbered, opaque envelopes containing an assignment to treat or placebo. Treatment assignments will be compiled using a list of computer generated pseudo-random numbers in permuted blocks of variable size. In patients with only one eye eligible for the study, the eye will be randomised to receive treatment with intravitreal triamcinolone or a sub-conjunctival injection. In patients with both eyes eligible for the study, the right eye will receive the treatment assignment in the envelope and the fellow eye will receive the reverse treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
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)

Funding & Sponsors
Funding source category [1] 388 0
Charities/Societies/Foundations
Name [1] 388 0
Sydney Eye Hospital Foundation
Address [1] 388 0
Sydney/Sydney Eye Hospital
Country [1] 388 0
Australia
Funding source category [2] 389 0
Other
Name [2] 389 0
The Ophthalmic Research Institute of Australia
Address [2] 389 0
Australia
Country [2] 389 0
Australia
Funding source category [3] 390 0
Charities/Societies/Foundations
Name [3] 390 0
The Juvenile Diabetes Research Foundation
Address [3] 390 0
Australia
Country [3] 390 0
Australia
Funding source category [4] 391 0
Charities/Societies/Foundations
Name [4] 391 0
The Diabetes Australia Research Trust
Address [4] 391 0
Australia
Country [4] 391 0
Australia
Primary sponsor type
Individual
Name
Professor Mark Gillies
Address
Save Sight Institute, Discipline of Clinical Ophthalmology and Eye Health, Sydney/Sydney Eye Hospital, Macquarie Street, Sydney 2000
Country
Australia
Secondary sponsor category [1] 320 0
None
Name [1] 320 0
No
Address [1] 320 0
Country [1] 320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1380 0
Save Sight Institute, Department of Clinical Ophthalmology and Eye Health University of Sydney
Ethics committee address [1] 1380 0
Ethics committee country [1] 1380 0
Australia
Date submitted for ethics approval [1] 1380 0
Approval date [1] 1380 0
Ethics approval number [1] 1380 0

Summary
Brief summary
The trial completed in May 2005. A open lable clinical trial (TDMX) is an extension of this study.
Trial website
Trial related presentations / publications
1. Sutter FK, Simpson JM, Gillies MC. Intravitreal triamcinolone for diabetic macular edema that persists after laser treatment: three-month efficacy and safety results of a prospective, randomized, double-masked, placebo-controlled clinical trial. Ophthalmology. 2004 ;111(11):2044-9. (IF:4.031)
2. Larsson J, Zhu M, Sutter F, Gillies MC. Relation between reduction of foveal thickness and visual acuity in diabetic macular edema treated with intravitreal triamcinolone. Am J Ophthalmol. 2005;139(5):802-6. (IF:2.468)
3. Gillies MC, Sutter FK, Simpson JM, Larsson J, Ali H, Zhu M. Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial. Ophthalmology. 2006;113(9):1533-8. (IF: 4.031)
Public notes

Contacts
Principal investigator
Name 35472 0
Address 35472 0
Country 35472 0
Phone 35472 0
Fax 35472 0
Email 35472 0
Contact person for public queries
Name 9413 0
Dr Meidong Zhu
Address 9413 0
Save Sight Institute
Department of Clinical Ophthalmology and Eye Health
University of Sydney
Sydney/Sydney Eye Hospital Campus
GPO Box 4337
NSW 2001
Country 9413 0
Australia
Phone 9413 0
+61 2 93827286
Fax 9413 0
+61 2 93827318
Email 9413 0
meidong@eye.usyd.edu.au
Contact person for scientific queries
Name 341 0
Professor Mark Gillies
Address 341 0
Save Sight Institute
Department of Clinical Ophthalmology and Eye Health
University of Sydney
Sydney/Sydney Eye Hospital Campus
GPO Box 4337
NSW 2001
Country 341 0
Australia
Phone 341 0
+61 2 93827309
Fax 341 0
+61 2 93827318
Email 341 0
mark@eye.usyd.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary