In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic Neuropathy (NSION) who had a sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided in two groups 1)control 2) case . In case group Avastin and Triamcinolone will be injected through vitrea and placebo will be injected in control group. BCVA and Visual field will be then measured in these two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT1138901221180N13
Registration date:2010-05-21, 1389/02/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-21, 1389/02/31
Registrant information
Name
pooya rostami
Name of organization / entity
Opthalmic Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 5952
Email address
labbafi@hotmail.com
Recruitment status
Recruitment complete
Funding source
Ophthalmic Research Center
Expected recruitment start date
2009-11-14, 1388/08/23
Expected recruitment end date
2011-11-14, 1390/08/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Intravitreal Bevacizumab and Triamcinolone with Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy
Public title
Comparison of Intravitreal Bevacizumab and Triamcinolone with Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (<30 days). Exclusion criteria: any eye disease except NAION (Nonarteritic Anterior Ischemic Optic Neuropathy), neurologic defect, abnormal ESR, CRP, any history of retina or vitrea surgery, severe corneal opacity which makes retina examination impossible.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ophthalmic Research Center
Street address
No 23, Pasdaran Ave, 9th Boostan
City
Tehran
Postal code
166666
Approval date
2010-02-22, 1388/12/03
Ethics committee reference number
ت چ،7527
Health conditions studied
1
Description of health condition studied
Anterior Ischemic of Optic Nerve
ICD-10 code
H47.0
ICD-10 code description
Disorders of optic nerve, not elsewhere classified
Primary outcomes
1
Description
BCVA
Timepoint
1,3, 6 months
Method of measurement
snellen chart
Secondary outcomes
1
Description
visual field
Timepoint
1,3,6 months
Method of measurement
snellen
Intervention groups
1
Description
Control: placebo
Category
Placebo
2
Description
Intervention: Avastin 1.25 mg and Triamcinolone 2 mg one time
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ophthalmic Research Center
Full name of responsible person
Ali-Asghar Aghdai
Street address
No 23,Pasdaran Ave, 9th Boostan
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ophthalmic Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ophthalmic Rsearch Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammad Pakravan
Position
Ophthalmologist
Other areas of specialty/work
Street address
No 23, Pasdaran Ave, 9 th Boostan, Ophthalmic Research Center
City
Ttehran
Postal code
166666
Phone
+98 21 2259 2200
Fax
Email
labbafi@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Morteza Entezari
Position
Ophthalmolgist
Other areas of specialty/work
Street address
N0 23, Pasdaran Ave, 9th Boostan, Ophthalmic Research Center
City
Tehran
Postal code
1666663111
Phone
+98 21 2276 6106
Fax
Email
labbafi@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pooya Rostami
Position
General physician
Other areas of specialty/work
Street address
No 23, Pasdaran Ave, 9th Boostan. Ophthalmic Research Center
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)