The purpose of the present study is to evaluate effect of Bevacizumab on recurrent pterygia. In this single arm clinical trial, all patients with recurrent pterygia referring to ophthalmology clinic of Baqiyatallah hospital for two months will be recruited and receive a single dose local injection of Bevacizumab and 20 patients had been estimated in this way. The pterygial size will be measured until 3 months after the intervention and compared with before intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010054856N1
Registration date:2011-05-02, 1390/02/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-02, 1390/02/12
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 Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local injection of Bevacizumab on pterygial size in patients with recurrence of pterygia
Public title
The effect of Bevacizumab on recurrent pterygia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Recurrence of pterygia after surgical excision
Exclusion criteria:
History of any other ophthalmic surgery
Age
No age limit
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
Ethic Commitee of Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of Medical Science, Molla sadra Avenue, Vanak Squre
City
Tehran
Postal code
193955487
Approval date
2010-11-24, 1389/09/03
Ethics committee reference number
25
Health conditions studied
1
Description of health condition studied
pterygium
ICD-10 code
H11.0
ICD-10 code description
Pterygium
Primary outcomes
1
Description
Pterygium size
Timepoint
Before intervention, 1 week, 1 month and 3 monthes after intervention
Method of measurement
mili meter with Slit Lamp
Secondary outcomes
1
Description
Angiogenesis
Timepoint
Befor intervention, 1 week, 1 month and 3 monthes after intervention
Method of measurement
Based on Fondues Camera picture.
Intervention groups
1
Description
Injection of 1.25 mg Bevacizumab in Pterygial Bed
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ophthalmology Clinic of Baqiyatallah Hospital
Full name of responsible person
Ali Alishiri MD. Assistant Professor of ophthalmology
Street address
Ophthalmology Clinic, Clinic of Baqiyatallah hospital, Molla Sadra Avenue, Vanak Squre
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 MD.
Street address
Vice Chancellor for research, Baqiyatallah university of medical science, Molla sadra Avenue, Vanak Squre, Tehran, Iran
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
Ophthalmology department of Baqiyatallah hospital
Full name of responsible person
Ali Alishiri MD.
Position
Associate Professor of ophthalmology, ophthalmology department, Baqiyatallah Hospital
Other areas of specialty/work
Street address
Baqiyatallah hospital, Molla sadra Avenue, Vanak Squre
City
Tehran
Postal code
Phone
+98 82162436
Fax
Email
ophthalmology110@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ophthalmology department of Baqiyatallah Hospital
Full name of responsible person
Ali Alishiri MD.
Position
Associate Professor of ophthalmology, ophthalmology department, Baqiyatallah hospital
Other areas of specialty/work
Street address
Ophthalmology department , Baqiyatallah Hospital, Molla sadra Avenue, Vanak Squre
City
Tehran
Postal code
Phone
+98 82162436
Fax
Email
ophthalmology110@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ophthalmology department of Baqiyatallah hospital
Full name of responsible person
Ali Alishiri MD.
Position
Associate Professor of Ophthalmology, ophthalmology department , Baqiyatallah hospital
Other areas of specialty/work
Street address
Ophthalmology department , Baqiyatallah hospital, Molla sadra Avenue, Vanak Squre
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)