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Trial registered on ANZCTR


Trial ID
ACTRN12614000375651
Ethics application status
Not yet submitted
Date submitted
2/04/2014
Date registered
8/04/2014
Date last updated
8/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Avastin in Trabeculectomy Study
Scientific title
A randomised double-blinded study to assess the ability for intravitreal bevacizumab to increase the proportion of glaucoma patients with intraocular pressure at or below target following glaucoma drainage surgery.
Secondary ID [1] 284384 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 291554 0
Condition category
Condition code
Eye 291936 291936 0 0
Diseases / disorders of the eye
Surgery 291960 291960 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single intraoperative intravitreal injection of bevacizumab 1.25mg in 0.05ml
Intervention code [1] 289114 0
Treatment: Drugs
Comparator / control treatment
A single intraoperative intravitreal injection of balanced-salt solution
Control group
Placebo

Outcomes
Primary outcome [1] 291840 0
Proportion of patients with intraocular pressure at or below target on no medication measured with goldmann applanation tonometry
Timepoint [1] 291840 0
One year
Primary outcome [2] 291841 0
Proportion of patients with intraocular pressure at or below target with or without topical medication measured with goldmann applanation tonometry
Timepoint [2] 291841 0
One year
Secondary outcome [1] 307645 0
Number of topical medications by data linkage to patient medical records
Timepoint [1] 307645 0
One year
Secondary outcome [2] 307646 0
Number of bleb needlings by data linkage to patient medical records
Timepoint [2] 307646 0
One year
Secondary outcome [3] 307647 0
Number of 5 Fluorouracil injections by data linkage to patient medical records
Timepoint [3] 307647 0
One year

Eligibility
Key inclusion criteria
Those requiring a trabeculectomy or a phaco-trabeculectomy based on the judgement of the treating surgeon
Minimum age
40 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anterior segment dysgenesis, irido-corneal-endothelial syndrome, proliferative diabetic retinopathy, congenital or juvenile-onset glaucoma, traumatic glaucoma, rubeotic glaucoma, previous corneal graft surgery, previous vitrectomy surgery requiring silicone oil, any condition for which the patient is currently receiving intravitreal anti-VEGF medication. However, previous cataract or trabeculectomy surgery is not an exclusion.

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)
Subjects will be selected from those attending glaucoma clinics at the Flinders Medical Centre and the Repatriation General Hospital eye outpatients department. Once a patient has been identified as being appropriate for the study, they will be invited to be involved. If they agree, then their details will be forwarded to the department of pharmacy at the Flinders Medical Centre where randomization will take place. Patients will be allocated to either receive an intravitreal injection of Avastin (1.25mg in 0.05ml) or a sham/placebo injection of balanced-salt solution. This injection will be dispensed to the surgeon who will administer it and the completion of the trabeculectomy surgery. Patients will then be followed by the surgeon over the following 12 months.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This will be achieved using a pseudorandom number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on previous work and when considering an IOP of less than 21 mmHg, the 1 year complete success rate for trabeculectomy surgery can be expected to be 85%. However, this target would not be considered a success in the advanced patients who are now requiring surgery. Therefore, we would be aiming for a lower target IOP, but with that we would also expect a lower success rate. We therefore feel that an expected complete success rate of 75% would be a conservative estimate. Furthermore, we would expect that an improvement in success rate of 20% would be required for a change in practice to occur. We would therefore aim to recruit a minimum of approximately 100 patients (50 cases and 50 controls). This would allow us to detect a difference of at least 20% between groups, with 80% power and type 1 error of 5%.

Recruitment
Recruitment status
Not yet 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)
SA
Recruitment hospital [1] 2291 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 2292 0
Repatriation Hospital - Daw Park
Recruitment postcode(s) [1] 7968 0
5042 - Bedford Park
Recruitment postcode(s) [2] 7969 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 289028 0
Self funded/Unfunded
Name [1] 289028 0
A/Prof John Landers
Address [1] 289028 0
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK SA 5042
Country [1] 289028 0
Australia
Primary sponsor type
Individual
Name
A/Prof John Landers
Address
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK SA 5042
Country
Australia
Secondary sponsor category [1] 287701 0
None
Name [1] 287701 0
Address [1] 287701 0
Country [1] 287701 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290832 0
South Adelaide Health Service Human Research Ethics Committee
Ethics committee address [1] 290832 0
Flinders University
1 Sturt Road
BEDFORD PARK SA 5042
Ethics committee country [1] 290832 0
Australia
Date submitted for ethics approval [1] 290832 0
14/04/2014
Approval date [1] 290832 0
Ethics approval number [1] 290832 0

Summary
Brief summary
Glaucoma is a progressive disease of the optic nerve, which if undiagnosed, can lead to blindness. Surgery is often reserved for very severe cases and as such, surgical success is imperative. Our project will address this by performing a randomised double blinded assessment of the adjunctive use of intraoperative intravitreal bevacizumab (Avastin), a currently available and widely used anti-VEGF drug, on post-operative glaucoma surgery success. If this intervention is successful, the outcomes could undoubtedly influence future surgical management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47418 0
A/Prof John Landers
Address 47418 0
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK SA 5042
Country 47418 0
Australia
Phone 47418 0
+61414804090
Fax 47418 0
Email 47418 0
john.landers@bigpond.com
Contact person for public queries
Name 47419 0
A/Prof John Landers
Address 47419 0
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK SA 5042
Country 47419 0
Australia
Phone 47419 0
+61414804090
Fax 47419 0
Email 47419 0
john.landers@bigpond.com
Contact person for scientific queries
Name 47420 0
A/Prof John Landers
Address 47420 0
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK SA 5042
Country 47420 0
Australia
Phone 47420 0
+61414804090
Fax 47420 0
Email 47420 0
john.landers@bigpond.com