Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000577415
Ethics application status
Approved
Date submitted
4/11/2007
Date registered
9/11/2007
Date last updated
9/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
EFFICACY AND SAFETY OF INTRAVITREAL AVASTIN IN EYES WITH NEOVASCULAR GLAUCOMA UNDERGOING AHMED GLAUCOMA VALVE IMPLANTATION
Scientific title
EFFICACY AND SAFETY OF INTRAVITREAL AVASTIN IN EYES WITH NEOVASCULAR GLAUCOMA UNDERGOING AHMED GLAUCOMA VALVE IMPLANTATION
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neovascular glaucoma 2525 0
Condition category
Condition code
Eye 2621 2621 0 0
Diseases / disorders of the eye
Eye 2634 2634 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The surgical procedure will consist of a 1-stage Ahmed Glaucoma Valve implantation using a standardized surgical technique. After administration of regional or general anesthesia, a fornix based conjunctival flap will be fashioned in the superotemporal quadrant. The anterior edge of the plate will be secured with 9-0 nylon sutures to the sclera at least 8 mm from the limbus. The tube tip will be cut obliquely to protect the tube lumen from the iris. A 23-gauge needle tract will be used to enter the anterior chamber through the limbus. The tube in the anterior chamber will be positioned anterior to the iris and away from the corneal endothelium. A donor sclera or a human pericardium patch graft will be fashioned from banked tissue and secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva will be sutured either with 8-0 or 9-0 polyglactin sutures or with 10-0 nylon sutures. The anterior chamber will be reformed with BSS through a paracentesis tract. Viscoelastic material will be injected into the anterior chamber at the surgeon’s discretion. At the end of surgery approximately 1.25 mg of bevacizumab (0.05 mL of commercially available bevacizumab at a concentration of 25 mg/mL) or 0.05 mL of sterille saline salt solution will be injected into the eye via pars plana with a 1.00-mL syringe attached to a 30-gauge needle.
The postoperative regimen will include a topical antibiotic and a cycloplegic for 2 to 4 weeks, and topical steroids for approximately 2 months. Antiglaucoma medication will be added as required to improve IOP reduction. Patients will be examined 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, and 18 months after surgery.
Intervention code [1] 2254 0
Treatment: Surgery
Comparator / control treatment
Ahmed valve implant + placebo (0.05 mL of sterille saline salt solution)
Control group
Placebo

Outcomes
Primary outcome [1] 3532 0
Intraocular pressure control.
The measure will be done with Goldman applanation tonometer.
Timepoint [1] 3532 0
at six months after randomisation
Secondary outcome [1] 5912 0
Safety of intravitreal bevacizumab in neovascular glaucoma
Timepoint [1] 5912 0
at six months after randomisation

Eligibility
Key inclusion criteria
All patients with uncontrolled neovascular glaucoma that underwent prior pan retinal photocoagulation requiring glaucoma drainage device implantation will be eligible.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients younger than 18 years; with learning difficulties, mental illness, or dementia; unconscious; or severely ill will not be included in the study.

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)
A computer program will generate the codes. A person who will not participate of data analysis will select the subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment outside Australia
Country [1] 644 0
Brazil
State/province [1] 644 0
Sao Paulo
Country [2] 645 0
Brazil
State/province [2] 645 0
S?o Paulo

Funding & Sponsors
Funding source category [1] 2766 0
Self funded/Unfunded
Name [1] 2766 0
Dr. Enyr Saran Arcieri
Country [1] 2766 0
Brazil
Funding source category [2] 2773 0
Self funded/Unfunded
Name [2] 2773 0
Country [2] 2773 0
Funding source category [3] 2774 0
Self funded/Unfunded
Name [3] 2774 0
Country [3] 2774 0
Primary sponsor type
Individual
Name
Dr. Enyr Saran Arcieri
Address
Av Getulio Vargas, 1700 - sl 4
Country
Brazil
Secondary sponsor category [1] 2499 0
None
Name [1] 2499 0
Address [1] 2499 0
Country [1] 2499 0
Secondary sponsor category [2] 2505 0
None
Name [2] 2505 0
Address [2] 2505 0
Country [2] 2505 0
Secondary sponsor category [3] 2506 0
None
Name [3] 2506 0
Address [3] 2506 0
Country [3] 2506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4694 0
Comite de Etica em Pesquisa - UNICAMP
Ethics committee address [1] 4694 0
Rua Tessalia Vieira de Camargo, 126
Ethics committee country [1] 4694 0
Brazil
Date submitted for ethics approval [1] 4694 0
Approval date [1] 4694 0
24/07/2007
Ethics approval number [1] 4694 0
0351.0.146.000-7

Summary
Brief summary
The aim of the study is to evaluate the impact of the intravitreal bevacizumab injection on the Ahmed valve implant surgical outcome on neovascular glaucoma patients without clinical control. The design is a prospective, randomized, clinical trial with 35 individuals. Those individuals who need a drainage implant surgery to control the intraocular pressure (IOP), will be randomized for intravitreal 1.0 mg bevacizumab injection (0.04 mL of the commercial bevacizumad solution with a concentration of 25 mg/mL) or 0.5 mL of balanced salt solution. “Surgical Success” will be defined as the following criteria: (1) postoperative IOP equal or less than 21 mmHg; or (2) 30% IOP reduction or more after the surgery, with or without glaucoma medication. Any other situation will be considered surgical failure. Statistical analysis will be performed with the chi-square and t Student’s tests, the success rates will be compared with Kaplan-Meier curve and the log rank test.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28161 0
Address 28161 0
Country 28161 0
Phone 28161 0
Fax 28161 0
Email 28161 0
Contact person for public queries
Name 11318 0
Dr. Enyr Saran Arcieri
Address 11318 0
Av Getúlio Vargas, 1700 - sl 4
Country 11318 0
Brazil
Phone 11318 0
55-34-32912400
Fax 11318 0
55-34-32912400
Email 11318 0
[email protected]
Contact person for scientific queries
Name 2246 0
Dr. Enyr Saran Arcieri
Address 2246 0
Av Getúlio Vargas, 1700 - sl 4
Country 2246 0
Brazil
Phone 2246 0
55-34-32912400
Fax 2246 0
55-34-32912400
Email 2246 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
SourceTitleYear of PublicationDOI
EmbaseAnti-vascular endothelial growth factor for neovascular glaucoma.2020https://dx.doi.org/10.1002/14651858.CD007920.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.