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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00167518




Registration number
NCT00167518
Ethics application status
Date submitted
5/09/2005
Date registered
14/09/2005
Date last updated
14/09/2005

Titles & IDs
Public title
Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)
Scientific title
Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment
Secondary ID [1] 0 0
ORIA Esme Anderson Grant
Secondary ID [2] 0 0
JDRF 1-2003-767
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
• Proportion of treated versus untreated eyes with improvement of visual acuity by 5 letters or more on the ETDRS chart at 24 months, no less than 3 months after the most recent treatment episode. An interim analysis of the primary and secondary outcome
Timepoint [1] 0 0
Primary outcome [2] 0 0
• Incidence of moderate or severe adverse effects related to treatment
Timepoint [2] 0 0
Secondary outcome [1] 0 0
• Any change of visual acuity (treated versus untreated eyes) at 3 months and 24 months after treatment
Timepoint [1] 0 0
Secondary outcome [2] 0 0
• Proportion of treated versus untreated eyes with reduction of macular thickness as demonstrated with OCT at 3 months and 24 months. Both absolute change and percentage change will be analysed.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
• Changes in semi-quantitative grading of cataract at 3 months and 24 months.
Timepoint [3] 0 0

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



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
1/03/2002
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
The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe and efficacious for patients with clinically significant diabetic macular oedema that is recalcitrant to conventional laser therapy
Trial website
https://clinicaltrials.gov/study/NCT00167518
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. doi: 10.1016/j.ophtha.2004.05.025.
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. doi: 10.1016/j.ajo.2004.12.054.
Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
O'Day RF, Barthelmes D, Zhu M, Wong TY, McAllister IL, Arnold JJ, Gillies MC. Intraocular pressure rise is predictive of vision improvement after intravitreal triamcinolone acetonide for diabetic macular oedema: a retrospective analysis of data from a randomised controlled trial. BMC Ophthalmol. 2014 Oct 21;14:123. doi: 10.1186/1471-2415-14-123.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00167518