Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Timepoint [1] 0 0
24 month
Secondary outcome [2] 0 0
Change in retinal thickness demonstrated on optical coherence tomography (OCT)
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
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
Sex
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
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
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
54
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT00148265