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Trial registered on ANZCTR


Registration number
ACTRN12611000888965
Ethics application status
Approved
Date submitted
12/08/2011
Date registered
19/08/2011
Date last updated
17/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Avastin versus Triamcinolone for Diabetic Macular Edema at the time of Cataract Surgery
Scientific title
Randomised, double-masked, controlled trial of intravitreal Avastin (bevacizumab) versus Triesence (triamcinolone) at the time of cataract surgery on the visual outcomes for patients with diabetic macular oedema
Secondary ID [1] 262823 0
Nil
Universal Trial Number (UTN)
Trial acronym
DIMECAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 270546 0
Cataracts 270601 0
Condition category
Condition code
Eye 270704 270704 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 270766 270766 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Avastin (bevacizumab) 1.25mg intravitreal injection, single dose administered immediately following cataract surgery
Intervention code [1] 269172 0
Treatment: Drugs
Comparator / control treatment
Arm 2: Triesence (triamcinolone) 4mg intravitreal injection, single dose administered immediately following cataract surgery
Control group
Active

Outcomes
Primary outcome [1] 269419 0
Best corrected visual acuity
Timepoint [1] 269419 0
1 month, 6 months and 12 months post cataract surgery
Secondary outcome [1] 287591 0
Central macular thickness measured on Optical Coherence tomography
Timepoint [1] 287591 0
1 month, 6 months and 12 months post cataract surgery
Secondary outcome [2] 287592 0
Comparison of time to retreatment between two groups (where treatment includes additional laser or intravitreal injections)
Timepoint [2] 287592 0
Up to twelve months
Secondary outcome [3] 287593 0
Rate and severity of adverse reactions, for example, intraocular pressure will be monitored and compared between groups. An IOP elevation will be consdiered mild if it is between 22-29mmHg, moderate if it is 30mmHg or above and severe if it requires surgical intervention. Rates of endophthalmitis (if any) will be compared between groups.
Details on all adverse events which the patients experience during the study will be recorded including its duration, the severity grade (mild, moderate, severe), its relationship to the study drug (suspected / not suspected) and the action(s) taken.
Timepoint [3] 287593 0
Each study visit (week 1, months 1,2,3,4,5,6,7,8,9,10,11,12)

Eligibility
Key inclusion criteria
Clinically significant macular oedema involving the fovea of the study eye at baseline OR which has occured within 24 months of study entry OR microaneurysms within the foveal avascular zone which are not amenable to treatment with laser

Cataract in the study eye which requires extraction in the opinion of the investigator
Minimum age
19 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Glaucoma with visual field defects or uncontrolled glaucoma

Past history of intraocular pressure rise >35mmHg following steroid treatment

Significant macular ischemia

Visual acuity of <6/60 in the fellow eye

Known allergies to the study medications

Systemic treatment with steroids >5mg prednisolone (or equivalent) daily

Intercurrent severe systemic disease or ocular infection

Women of childbearing potential not using adequate contraception or women who are breastfeeding

Intravitreal triamcinolone within 10 weeks of study entry

Intravitreal Avastin within 3 weeks of study entry

Argon laser photocoagulation within 3 months prior to study entry

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)
Umaksed study coordinator will have a series of serially numbered, opaque envelones containing assignment to 'Avastin' or 'Triamcinolone'. One the day of the patients cataract surgery, unmasked doctor will contact unmasked study coordinator to assign next envelope to patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment assignments will be compiled using a list of computer generated pseud-random numbers in permuted blocks of variable size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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
Primary sponsor type
Hospital
Name
Royal Victorian Eye and Ear Hospital
Address
32 Gisborne Street
East Melbourne, Vic 3002
Country
Australia
Secondary sponsor category [1] 266679 0
None
Name [1] 266679 0
Address [1] 266679 0
Country [1] 266679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269593 0
Royal Victorian Eye and Ear Hospital Human Research Ethics Committee
Ethics committee address [1] 269593 0
32 Gisborne Street
East Melbourne
Vic 3002
Ethics committee country [1] 269593 0
Australia
Date submitted for ethics approval [1] 269593 0
Approval date [1] 269593 0
02/12/2010
Ethics approval number [1] 269593 0
10/973H

Summary
Brief summary
This study will compare two medications (Avastin (bevacizumab) and Triesence (Triamcinolone) given at the time of cataract surgery for patients with, or at high risk of developing, diabetic macular oedema. Patients will be seen monthly and outcomes include visual acuity, centra macular thickenss, time to retreatment and assesment of adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33009 0
Dr Lyndell Lim
Address 33009 0
Centre For Eye Research Australia
Level 1, 32 Gisborne Street
East Melbourne Victoria 3002
Country 33009 0
Australia
Phone 33009 0
+61 3 99298076
Fax 33009 0
Email 33009 0
limllp@unimelb.edu.au
Contact person for public queries
Name 16256 0
Ms Julie Morrison
Address 16256 0
Centre for Eye Research Australia
32 Gisborne Street
East Melbourne
Vic 3002
Country 16256 0
Australia
Phone 16256 0
+61 3 9929 8076
Fax 16256 0
+61 3 9929 8030
Email 16256 0
jl.morrison@unimelb.edu.au
Contact person for scientific queries
Name 7184 0
Dr Dr Lyndell Lim
Address 7184 0
Centre for Eye Research Australia
32 Gisborne Street
East Melbourne
Vic 3002
Country 7184 0
Australia
Phone 7184 0
+61 3 9929 8399
Fax 7184 0
+61 3 9929 8030
Email 7184 0
limllp@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
No Results