22 patients in first week of branch retinal vein occlusion(BRVO) onset that were diagnosed with flurcein angiography(FA), were treated with intravitreal injection of 1.25 mg of bevacizumab. Patients with initial diagnose of BRVO based on examination with slit lamp that have less than one week symptoms onset were included. Patients with other pathologies of retinal vessels beside BRVO based on flurcein angiography and who have received any medication for BRVO were excluded. Macular thickening with Optical Coherence Tomography(OCT) and visual acuity mesured before injection and 1,3 and 6 to 16 monthes after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106214856N2
Registration date:2011-07-03, 1390/04/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-03, 1390/04/12
Registrant information
Name
Mostafa Naderi
Name of organization / entity
Baqiyatollah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8216 2436
Email address
ophthalmology110@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Science
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcoms of intravitreal injection of bevacizumab in patients with acute
Branch retinal Vein Occlusion(BRVO)
Public title
Intravitreal Bevacizumab in acute Branch Retinal Vein Occlusion(BRVO)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Patients with initial diagnose of branch retinal vein occlusion(BRVO) based on examination with Slit Lamp; Less than one week of symptoms onset.
Exclusion: Other pathologies of retinal vessels beside BRVO based on flurcein angiography(FA); Patients that have recevied any medication for BRVO.
Age
From 35 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of medical Science, Mollasadra Avenu, Vanak Squre.
City
Tehran
Postal code
Approval date
2011-02-09, 1389/11/20
Ethics committee reference number
26
Health conditions studied
1
Description of health condition studied
Branch Retinal Vein occlusion
ICD-10 code
H34.8
ICD-10 code description
Other retinal vascular occlusions
Primary outcomes
1
Description
Macular Thickness
Timepoint
Befor injection and 1,3 and 6 to 16 monthes after injection
Method of measurement
Optical Coherence Tomography(OCT)
Secondary outcomes
1
Description
Visual accuity
Timepoint
Before injection and 1,3 and 6 to 16 monthes after injection
Method of measurement
Snelen Chart
Intervention groups
1
Description
Intravitreal single dose injection of 1.25 mg Bevacizumab(Avastin) at the begining of study for all 22 patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ophthalmology Clinic of Baqiyatallah Hospital.
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Baqiyatallah University of Medical Science
Full name of responsible person
Morteza Ezadi
Street address
Baqiyatallah Faculty of Medicine, Baqiyatallah University of Medical Science, Mollasadra Avenue, Vanak Squre
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Baqiyatallah University of Medical Science
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
General Practitioner, Department of ophthalmology, Baqiyatallah Hospital, Baqiyatallah University of