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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00148265




Registration number
NCT00148265
Ethics application status
Date submitted
6/09/2005
Date registered
7/09/2005
Date last updated
23/06/2010

Titles & IDs
Public title
A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema
Scientific title
Phase II/III Multicentre Randomised Clinical Trial of Laser Treatment Plus 4 mg Intravitreal Triamcinolone Injection to Reduce Diabetic Macular Oedema
Secondary ID [1] 0 0
NHMRC project 352312
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
Eyes assigned to IVTA received an intravitreal injection of 0.1 ml of Kenacort 40© [40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia] on the day of the baseline visual acuity measurement under sterile conditions in a minor procedures area as an outpatient procedure. Eyes assigned to placebo were prepared in the same way but had the barrel of the syringe without a needle pushed firmly against the eye to simulate an injection.

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

Outcomes
Primary outcome [1] 0 0
The proportion of eyes showing an improvement of visual acuity by 10 letters on a LogMAR chart compared with the pre-injection level 24 months after treatment - At 24 months, improvement of =10 LogMAR letters was seen in 15/42 (36%) eyes treated with IVTA plus laser compared with 7/42 (17%) eyes treated with laser only (p=0.047, odds ratio 2.79, 95% CI, 1.01, 7.67).
Timepoint [1] 0 0
24 month
Secondary outcome [1] 0 0
Number of laser treatments required for the treatment of macular oedema during the course of the study. - At least 1 retreatment was required in the second year of the study in 29/42 (69%) of IVTA plus laser treated eyes compared with 19/42 (45%) laser only eyes (p=0.187).
Timepoint [1] 0 0
24 month
Secondary outcome [2] 0 0
Change in retinal thickness demonstrated on optical coherence tomography (OCT) - There was no difference in the mean CMT (346.8µm ± 114.9SD vs 372.6µm ± 154.2SD, comparing IVTA plus laser vs laser only, p=0.349) or mean logMAR visual acuity (56.1 ± 15.7SD vs 54.5 ± 16.1SD letters, p=0.439).
Timepoint [2] 0 0
24 month
Secondary outcome [3] 0 0
The incidence of moderate or severe side effects related to the procedure of intravitreal injection or related to the drug - Cataracts were removed from 17/28 (61%) of phakic IVTA plus laser-treated eyes vs. 0/27 (0%) laser only eyes (p<0.001). Treatment for elevated intraocular pressure was required in 27/42 (64%) of the IVTA plus laser eyes compared with 10/42 (24%) laser only eyes (p<0.001)
Timepoint [3] 0 0
24 month

Eligibility
Key inclusion criteria
- Age >= 18 years

- Diagnosis of diabetes mellitus types 1 or 2

- Diabetic macular oedema affecting the fovea in one or both eyes (phakic or
pseudophakic) for which laser treatment is indicated in the opinion of the
investigator

- Best corrected visual acuity of 19-68 letters (6/12 -6/120)

- Definite macular oedema on clinical examination involving the centre of the macula

- Retinal thickness > 250 micron in central 1mm subfield on OCT

- Investigator is comfortable deferring macular laser treatment for 6 weeks
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Glaucoma which is uncontrolled or is controlled but with glaucomatous field defects

- Loss of vision due to other causes (e.g. age related macular degeneration, myopic
macular degeneration, retinal vein occlusion)

- Macular oedema due to other causes including vitreous traction

- An ocular condition that would prevent visual acuity improvement despite resolution of
oedema (such as foveal atrophy)

- Previous treatment IVTA within 6 months or with peribulbar TA within 3 months

- Cataract surgery within the last 6 months

- Retinal laser treatment within the last 4 months

- High risk PDR at baseline or laser therapy cannot be delayed for 6 weeks on retina

- History of herpes viral disease in study eye

- Media opacity including cataract that already precludes adequate macular photography
and laser treatment, or cataract that is likely to preclude an adequate view within 2
years

- 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)

- History of chronic renal failure requiring dialysis or renal transplant

- Blood pressure >180/110 mmHg

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Western Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Marsden Eye Specialists
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is likely to identify an improved and economical treatment for diabetic macular
oedema, one of the commonest causes of blindness both in Australia and the rest of the
world.The specific aims of the study are to test the following hypotheses:

- That intravitreal triamcinolone followed by laser treatment results in a greater
improvement in visual acuity than placebo followed by laser treatment of eyes with
macular oedema secondary to diabetes;

- That intravitreal triamcinolone followed by laser treatment results in greater degree of
resolution of macular oedema than placebo followed by laser treatment of eyes with
macular oedema secondary to diabetes;

- That intravitreal triamcinolone followed by laser treatment results in a reduced
requirement for further laser treatment to control diabetic macular oedema than placebo
followed by laser treatment;

- That intravitreal triamcinolone followed laser has a manageable and acceptable safety
profile in eyes with diabetic macular edema.
Trial website
https://clinicaltrials.gov/show/NCT00148265
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.
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