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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00148330




Registration number
NCT00148330
Ethics application status
Date submitted
6/09/2005
Date registered
7/09/2005
Date last updated
30/06/2010

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
Secondary ID [1] 0 0
NHMRC project 402573
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
Treatment: Drugs - Triamcinolone acetate

Treatment: Drugs: Triamcinolone acetate
When indicated, intravitreal triamcinolone (0.1 ml of Kenacort 40© [40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia]) was injected into the vitreous under sterile conditions in a minor procedures area.

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

Outcomes
Primary outcome [1] 0 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. - Changes from Baseline to 5 years: Improvement of =5 letters after 5 years was found in 14/33 (42%) eyes initially treated with triamcinolone compared with 11/34 (32%) eyes initially treated with placebo (zGEE=0.81, P=0.4).
Changes from 2 to 5 years (open-label extension):Improvement of =5 letters of best-corrected visual acuity was found in 8/29 (28%) eyes initial-triamcinolone compared with 7/28 (25%) initial-placebo eyes (zGEE=0.20, P=0.8).
Timepoint [1] 0 0
3 year extension, total 5 years study from baseline
Primary outcome [2] 0 0
Incidence of moderate or severe adverse events over the 3 years of the open-label extension - The incidence of cataract surgery declined in the third year: 5/11 (45%) eyes from the initial-triamcinolone group that were phakic at the beginning of the 3rd year required cataract surgery.
Timepoint [2] 0 0
3 year extension study, total 5 year study from baseline
Secondary outcome [1] 0 0
Change in macular thickness by OCT - Changes from Baseline to 5 years: Foveal thickness had decreased by 30µm (95% confidence interval, -47 to 107µm) less in the initial-triamcinolone group than in the initial-placebo group at 5 years (zGEE=0.76, P=0.45).
Changes from 2 to 5 years (open-label extension):Foveal thickness had actually increased slightly on average in the initial-triamcinolone group, but decreased in initial-placebo eyes. Overall it had decreased by 70µm (95% confidence interval, -1 to 140µm) more in the placebo group than in the treatment group between 2 and 5 years (zGEE=1.93, P=0.05).
Timepoint [1] 0 0
3 year extension, total 5 year study from the baseline
Secondary outcome [2] 0 0
Any change in visual acuity - Loss of ten or more letters was found in 6/33 (18%) initial-triamcinolone eyes compared with 8/34 (24%) initial-placebo eyes.
Timepoint [2] 0 0
3 year extension, total 5 year study from the baseline
Secondary outcome [3] 0 0
Number of laser treatments required. - During the third to fifth years of the study, a similar proportion of eyes from the 2 groups had macular edema that warranted laser treatment: initial-triamcinolone, 5/29 (17%); initial-placebo, 6/28 (21%).
Timepoint [3] 0 0
3 year extension study, total 5 year study from baseline

Eligibility
Key inclusion criteria
Participation in the study will be offered to 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 study that had reduced vision from diabetic macular oedema at baseline.
Minimum age
18 Years
Maximum age
No limit
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)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
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
This open label extension will treat all the eyes of study participants with active study
medication (intravitreal triamcinolone) as well as standard laser treatment where
appropriate.

The specific aims will be to test the following hypotheses:

- That intravitreal triamcinolone for diabetic macular oedema that persists or recurs
after laser treatment remains efficacious over five years

- That intravitreal triamcinolone for diabetic macular oedema that persists or recurs
after laser treatment retains a manageable and acceptable safety profile over five years
Trial website
https://clinicaltrials.gov/show/NCT00148330
Trial related presentations / publications
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 Nov;111(11):2044-9.
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 May;139(5):802-6.
Kuo CH, Gillies MC. Role of steroids in the treatment of diabetic macular edema. Int Ophthalmol Clin. 2009 Spring;49(2):121-34. doi: 10.1097/IIO.0b013e31819fcce8. Review.
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

Summary results
Other publications