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Trial registered on ANZCTR


Registration number
ACTRN12609000716268
Ethics application status
Approved
Date submitted
9/08/2009
Date registered
20/08/2009
Date last updated
20/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of intracameral Bevacizumab injection on corneal endothelial cells: an in vivo evaluation
Scientific title
Effect of intracameral Bevacizumab injection on corneal endothelial cells in patients with iris neovascularization: an in vivo evaluation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Corneal endothelial toxicity 243484 0
Condition category
Condition code
Eye 239784 239784 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single injection of intracameral Bevacizumab at a concentration of 1.25 mg/0.05 mL for the treatment of iris neovascularization
Intervention code [1] 237102 0
Treatment: Drugs
Comparator / control treatment
Two sessions of Pan retinal laser photocoagulation. Each comprising 500-700 shots over 15 minutes.one session each week for two weeks
Control group
Active

Outcomes
Primary outcome [1] 240552 0
endothelial cell density.The Noncon Robo Pachy Model SP-9000LC specular microscope (Konan Medical Corporation, Miyanishi-cho, Nishinomiya, Hyogo, Japan) was used to record the central corneal endothelial image and measures the corneal thickness. A KSS-300 Image Storage System (Konan Medical Corporation, Miyanishi-cho, Nishinomiya, Hyogo, Japan) was used to capture and save the image from the Noncon Robo specular microscope. The KSS-300 Image Storage System was later used to analyze the corneal endothelial image, using the centre method after counting a minimum of 10 cells in each eye.
Timepoint [1] 240552 0
4 weeks post treatment
Secondary outcome [1] 257134 0
endothelial cell morphology.The Noncon Robo Pachy Model SP-9000LC specular microscope (Konan Medical Corporation, Miyanishi-cho, Nishinomiya, Hyogo, Japan) was used to record the central corneal endothelial image and measures the corneal thickness. A KSS-300 Image Storage System (Konan Medical Corporation, Miyanishi-cho, Nishinomiya, Hyogo, Japan) was used to capture and save the image from the Noncon Robo specular microscope. The KSS-300 Image Storage System was later used to analyze the corneal endothelial image, using the centre method after counting a minimum of 10 cells in each eye.
Timepoint [1] 257134 0
4 weeks post treatment
Secondary outcome [2] 257136 0
regression of iris neovascularization will be assessed by performing anterior segment flourescein angiography before injection and 4 weeks after the injection and comparing them
Timepoint [2] 257136 0
4 weeks post treatment

Eligibility
Key inclusion criteria
patients with iris neovascularization
Minimum age
38 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
corneal edema or preoperative corneal endothelial desnity<1500 cells/mm2

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
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 1939 0
Egypt
State/province [1] 1939 0

Funding & Sponsors
Funding source category [1] 237477 0
University
Name [1] 237477 0
Cairo University Hospital
Address [1] 237477 0
84 shehab street
Mohandeseen
Giza
12411
Country [1] 237477 0
Egypt
Primary sponsor type
University
Name
Cairo University Hospital
Address
84 shehab street
Mohandeseen
Giza 12411
Country
Egypt
Secondary sponsor category [1] 236962 0
None
Name [1] 236962 0
Address [1] 236962 0
Country [1] 236962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239601 0
Ethics committee of Cairo University Hospital
Ethics committee address [1] 239601 0
Ethics committee country [1] 239601 0
Egypt
Date submitted for ethics approval [1] 239601 0
19/10/2008
Approval date [1] 239601 0
15/11/2008
Ethics approval number [1] 239601 0

Summary
Brief summary
This study is to evaluate the effect of a drug that decreases the growth of immature blood vessels that cause complications in the eye due to some diseases like diabetes. Its effect has been studied on the deep layers of the eye when injected in front of the retina, but this study evaluates its potential toxicity on the front side of the eye when injected just behind the cornea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30027 0
Address 30027 0
Country 30027 0
Phone 30027 0
Fax 30027 0
Email 30027 0
Contact person for public queries
Name 13274 0
Dr Mohamed Hosny
Address 13274 0
84 Shehab street
Mohandeseen
Giza
12411
Country 13274 0
Egypt
Phone 13274 0
0020122112617
Fax 13274 0
Email 13274 0
mohamedhosny@mac.com
Contact person for scientific queries
Name 4202 0
mohamed Hosny
Address 4202 0
84 shehab street
Mohandeseen
Giza,12411
Country 4202 0
Egypt
Phone 4202 0
0020122112617
Fax 4202 0
Email 4202 0
mohamedhosny@mac.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary