Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000318482
Ethics application status
Approved
Date submitted
8/06/2007
Date registered
14/06/2007
Date last updated
18/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Avastin in the prevention of postoperative scarring after glaucoma filtration surgery.
Scientific title
Does Avastin provide an additional antiscarring benefit to patients undergoing a trabeculectomy to improve the function of their filtration bleb and thus better maintain their target intraocular pressure postoperatively?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma, uncontrolled intraocular eye pressure, trabeculectomy, postoperative intervention, subconjunctival delievery. 1864 0
Condition category
Condition code
Eye 1960 1960 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Particpants will be invited into the study if they suit the eligibility criteria.
Written informed consent will be obtained from all participants.
Participants will be randomised into a treatment group or a control group.
Patients are randomised by opening a masked envelope that contains a randomisation group category generated by a computer based sequence table.
All Participants will have the standard antiscarring treatment (5 FU) and if the participant is randomised into the treatment group, will then receive the additional study drug (Avastin).
A thorough eye examination and photos of the surgical/treatment site will be performed at all follow up visits.
Study Drug Dose = a single 1mg dose.
Mode of Administration of Study Drug = dose is administered according to the established clinical hospital protocol for antifibrotic agents given via a
subconjunctival injection into the filtration bleb.
Study Drug Duration = A single injection of the study drug is given with an expected half life of up to 20 days.
Intervention code [1] 1769 0
Treatment: Drugs
Comparator / control treatment
Standard antiscarring treatment (5 FU)
Control group
Active

Outcomes
Primary outcome [1] 2775 0
Number of participants with an intraocular eye pressure >8mmHg and <21mmHg with no topical therapy
Timepoint [1] 2775 0
At 3 months post treatment
Secondary outcome [1] 4675 0
Bleb vascularity and morphology (graded by a masked observer according to Moorfields bleb grading scheme).
Timepoint [1] 4675 0
At 1, 6 and 12 week follow up appointment time points.

Eligibility
Key inclusion criteria
Patients within 4 weeks of their first trabeculectomy who are deemed on clinical grounds to require the standard antiscarring treatment (5 FU).
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active or recent bleb leak, known hypersensitivity to 5 FU, only eye, active bleb inflammation, inability to complete the informed consent, uncontrolled systemic condition within the previous month.

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 were selected from a convenience sample of patients attending the Royal Victorian Eye and Ear Hospital. Specifically, postoperative patients that met the inclusion and exclusion criteria were invited to participate. If written informed consent was obtained and all questions answered, the study coordinator presented the participant with a concealed envelope that contained a randomisation number. The treatment allocation envelopes match the chronological subject order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation generation: performed using a computer based random sequence table arranged and monitored by an individual outside of the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participants, the study consultants and other members of the research team will be masked to the baseline treatment visit (when randomisation number revealed) whilst the outcome grade assessor will be masked throughout the study.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 591 0
3002

Funding & Sponsors
Funding source category [1] 2099 0
University
Name [1] 2099 0
Monash University
Country [1] 2099 0
Australia
Funding source category [2] 3125 0
Hospital
Name [2] 3125 0
Royal Victorian Eye and Ear Hospital
Country [2] 3125 0
Australia
Primary sponsor type
University
Name
Monash Universtity
Address
City Office 30 Collins St, Melbourne, Victoria 3000
Country
Australia
Secondary sponsor category [1] 1905 0
Other
Name [1] 1905 0
Centre for Eye Research Australia
Address [1] 1905 0
Glaucoma Research Lab, 32 Gisborne Street, East Melbourne, VIC, 3002
Country [1] 1905 0
Australia
Secondary sponsor category [2] 1906 0
Hospital
Name [2] 1906 0
Royal Victorian Eye and Ear Hospital
Address [2] 1906 0
32 Gisborne Street, East Melbourne, VIC, 3002
Country [2] 1906 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3891 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 3891 0
Ethics committee country [1] 3891 0
Australia
Date submitted for ethics approval [1] 3891 0
Approval date [1] 3891 0
04/01/2007
Ethics approval number [1] 3891 0
06/714H

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27872 0
Address 27872 0
Country 27872 0
Phone 27872 0
Fax 27872 0
Email 27872 0
Contact person for public queries
Name 10958 0
Ms Queen Qin
Address 10958 0
Centre for Eye Research Australia
Glaucoma Investigation and Research Unit
Level 1
32 Gisborne Street
East Melbourne VIC 3002
Country 10958 0
Australia
Phone 10958 0
+61 3 99298195
Fax 10958 0
+61 3 99298657
Email 10958 0
[email protected]
Contact person for scientific queries
Name 1886 0
Professor Jonathan Crowston
Address 1886 0
Centre for Eye Research Australia
Glaucoma Investigation and Research Unit
Level 1
32 Gisborne Street
East Melbourne VIC 3002
Country 1886 0
Australia
Phone 1886 0
+61 3 99298196
Fax 1886 0
+61 3 99298657
Email 1886 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.