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Trial registered on ANZCTR


Trial ID
ACTRN12605000244606
Ethics application status
Approved
Date submitted
22/08/2005
Date registered
31/08/2005
Date last updated
18/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema (TDMX study)
Scientific title
An open Label Extension of the phase II/III clinical trial of intravitreal triamcinolone on the effects and safety of clinically significant diabetic macular oedema that persists after laser treatment
Universal Trial Number (UTN)
Trial acronym
TDMX study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 331 0
Condition category
Condition code
Metabolic and Endocrine 380 380 0 0
Diabetes
Eye 381 381 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Results from our own randomised clinical trial, combined with anecdotal reports from other groups, suggests that intravitreal triamcinolone safely improves vision and reduces swelling for up to 2 years in most eyes with diabetic macular oedema which persists or recurs despite laser treatment. There are no data on longer term efficacy and safety. We will conduct an open-label extension of a prospective, single centre, double-masked, placebo-controlled clinical trial of IVTA for diabetic macular oedema that persists or recurs after laser treatment. Sixty four of the originally enrolled 69 (93%) eyes are available to be followed. Triamcinolone (0.1 ml Kenacort 40, 40mg/ml triamcinolone acetate, Bristol-Myers Squibb pharmaceuticals, Australia) will be injected into the vitreous in eyes which have persistent macular oedema (>250 micron) AND visual acuity of 6/9 or worse. Treatment will be withheld at the investigator’s discretion if 2 previous injections have failed to significantly (50 micron) reduce macular oedema. The duration of the patient follow-up is 3 years and the duration of the entire study is 4 years.
Intervention code [1] 225 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Uncontrolled

Outcomes
Primary outcome [1] 438 0
Increase of >=5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit.
Timepoint [1] 438 0
At baseline, 2 years and 5 years.
Primary outcome [2] 439 0
Incidence of moderate or severe adverse events over the 3 years of the open-label extension
Timepoint [2] 439 0
at baseline, 2 years and 5 years
Secondary outcome [1] 967 0
Change in macular thickness by OCT.
Timepoint [1] 967 0
up to 5 years follow up
Secondary outcome [2] 968 0
Any change in visual acuity.
Timepoint [2] 968 0
up to 5 years follow up
Secondary outcome [3] 969 0
Number of laser treatments required.
Timepoint [3] 969 0
up to 5 years follow up

Eligibility
Key inclusion criteria
All patients at the conclusion of the TDMO study. Currently we are still following 64 of the 69 (93%) eyes that were initially entered into the TDMO study that had reduced vision from diabetic macular oedema at baseline.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled glaucoma; Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration);known allergies to triamcinolone acetate; patient is already receiving systemic steroid treatment; intercurrent severe disease such as septicemia; 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
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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] 435 0
Government body
Name [1] 435 0
Applied for NHMRC project grant 2006 (#402573)
Address [1] 435 0
Australia
Country [1] 435 0
Australia
Funding source category [2] 4974 0
Government body
Name [2] 4974 0
NHMRC project grant 402573
Address [2] 4974 0
Australia
Country [2] 4974 0
Australia
Primary sponsor type
Individual
Name
Professor Mark Gillies
Address
Save Sight Institute
Department of Clinical Ophthalmology and Eye Health
Country
Australia
Secondary sponsor category [1] 353 0
None
Name [1] 353 0
No
Address [1] 353 0
Country [1] 353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1404 0
SESIAHS Northern Network Human Research Ethics Committee
Ethics committee address [1] 1404 0
NSW Australia
Ethics committee country [1] 1404 0
Australia
Date submitted for ethics approval [1] 1404 0
Approval date [1] 1404 0
01/10/2004
Ethics approval number [1] 1404 0
05/272

Summary
Brief summary
We will conduct an open-label extension of a prospective, single centre, double-masked, placebo-controlled clinical trial of IVTA for diabetic macular oedema that persists or recurs after laser treatment. Sixty four of the originally enrolled 69 (93%) eyes are available to be followed. The primary outcome measures will be an increase of =5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit. The incidence of moderate or severe adverse events over the 3 years of the open-label extension will also be a primary outcome. Secondary outcomes will include change in macular thickness by OCT, any change in visual acuity and number of laser treatments required. Standardised protocols have been developed for intravitreal injection, macular laser treatment, refraction and measurement of visual acuity. Treatment with triamcinolone will be offered to all patients, whether they previously received placebo or active treatment, on exit from the TDMO study. IVTA will be administered in the clinic under local anaesthesia. Treatments will be given at least 6 months apart according to prospectively identified criteria that take into account the previous and current visual acuity and macular thickness measured by OCT. The safety data will be monitored 6 monthly by an independent Safety Monitoring Committee.
Trial website
Trial related presentations / publications
1. Larsson J, Kifley A, ZhuM, Want JJ, Mitchell P, Sutter FKP, Gillies MC. Rapid reduction of
hard exudates in eyes with diabetic retinopathy after intravitreal triamcinolone - Data from a
randomized, placebo controlled clinical trial. Acta Ophthalmologica in press, acceptance date:
Feb 4 2008 (IF:1.458)
2. Gillies MC, Islam FM, Zhu M, Larsson J, Wong TY. Efficacy and safety of multiple
intravitreal triamcinolone injections for refractory diabetic macular oedema. Br J Ophthalmol.
2007; 91:1323-6. (IF:2.524)
3. Gillies MC, Sutter FK, Simpson JM, Larsson J, Ali H, Zhu M. Intravitreal triamcinolone for
refractory diabetic macular oedema: two-year results of a double-masked, placebo-controlled,
randomized clinical trial. Ophthalmology. 2006;113:1533-8. (IF:4.031)
4. Gillies MC, Simpson JM, Gaston C, Hunt G, Ali H, Zhu M, Sutter FKP. 5-year results of a randomized clinical trial with open label extension of intravitreal triamcinolone for refractory diabetic macular edema. Ophthalmology, In Press accepted 16.1.09.
Public notes

Contacts
Principal investigator
Name 35885 0
Address 35885 0
Country 35885 0
Phone 35885 0
Fax 35885 0
Email 35885 0
Contact person for public queries
Name 9414 0
Dr Christine Gaston
Address 9414 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 9414 0
Australia
Phone 9414 0
+61 2 93827309
Fax 9414 0
+61 2 93827318
Email 9414 0
cgaston@eye.usyd.edu.au
Contact person for scientific queries
Name 342 0
Professor Mark Gillies
Address 342 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 342 0
Australia
Phone 342 0
+61 2 93827309
Fax 342 0
+61 2 93827318
Email 342 0
mark@eye.usyd.edu.au