Protocol summary

Summary
Aim: Evaluation of intravitreal injection of Bevascizumab for treatment of chronic central serous chorioretinopathy . Design:Prospective, Consecutive , non randomized Clinical Trial. Participants and Intervention: 15 patient of Acutec Central Serous Chorioretinopathy That is not Anatomically improved for more than 4-months(Persistant Macular Sub-Sensory Retinal Fluid )will recive 0.1 cc/2.5 mg of Avastin Intravitrealy .Before Injection ,The dignosis should be Confirmed by Ocular Coherent Tomography(OCT) and Fluorescien Angiography (FFA) .Also all the Patients will be examine by an another ophtalmologist (Supervisor of The Study )and The diagnosis of the Chronic Central Serous Chorioretinopathy should be Confirmed by him.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202198983N1
Registration date: 2012-03-17, 1390/12/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Mohammad rasoul Sabouri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 6886
Email address
sabouri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan university of medical sciences
Expected recruitment start date
2012-02-19, 1390/11/30
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Intravitreal injection of Bevacizumab for treatment of Chronic Central Serous Chorioretinopathy
Public title
Evaluation of Intravitreal injection of Bevacizumab for treatment of Chronic Central Serous Chorioretinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 1- patient by Acute Central Serous Chorioretinopathy for more than 4-months. 2- Comformation of The Chronic Central Serous Chorioretinopathy byOcular Coherent Tomography(OCT) and Fluorescien Angiography (FFA) . 3- comfirmation of the Diseasis by Supervisor of Study. Exclusion criteria: 1- Chronic Central Serous Chorioretinopathy more than 2 years. 2- History of Treatment by any type of Laser. 3-History of Thromboambolic Diseasis Like Myocardial Infarction and Cerebro Vascular accident. 4- History of Treatment by Intravitreal Avastin during 2 months ago. 5- any sistemic Diseasis that need Oral Corticosteroid Thrapy. 6- un - Controled Glaucoma 7- Pregnancy 8- Lack of agreement by Patient for periodic Follow up during study.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
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
Guilan University of Medical Sciences
Street address
Amiralmomenin Hospital, 17 Shahrivar Ave, Rasht, Guilan, Iran
City
Rasht
Postal code
4139637459
Approval date
2012-01-11, 1390/10/21
Ethics committee reference number
1901130501

Health conditions studied

1

Description of health condition studied
chronic central serous chorioretinopathy
ICD-10 code
VII
ICD-10 code description
Disease of the eye and adnexa

Primary outcomes

1

Description
Vision Improvement
Timepoint
every 6 to 8 weeks untill 6 month
Method of measurement
Snelen Chart

2

Description
Anatomical Improvement
Timepoint
every 6 to 8 weeks untill 6 month
Method of measurement
Clinical exam and OCT

Secondary outcomes

1

Description
centeral thickness of retin
Timepoint
per 6-8 weeks till 6 month
Method of measurement
with OCT.If in the first examination( by OCT) after weeks 6 to 8 ,at least 10 % reduction in the central macular thickness occur,the patient will be periodically follow,if not ,the patient will be omitted.

Intervention groups

1

Description
In the operating room, under local anesthesia, and MAC and sterile condition by using 10% & 5% Betadine for periorbital and culdesac area and prep & drape and insertion of speculum and after 0.1 cc AC-tap ,0.1cc/2.5 mg Bevacizumab(Avastin) will be injected through superior / inferior temporal quadran 3.5 mm away from limbous using 30- guage needle
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
dr mohammad rasoul sabouri
Street address
17 shahrivar street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan Universoty of Medical Sciences, Pro-vice-chancellor for resea
Full name of responsible person
Susan Komaie
Street address
Pro-vice Chancellor for Research , Namjoo Ave, Mellat St, Rasht, Guilan, Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan Universoty of Medical Sciences, Pro-vice-chancellor for resea
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
Guilan university of Medical Sciences
Full name of responsible person
Dr Mohammad Rasoul Sabouri
Position
Assistant Professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital, 17 Shahrivar Ave, Rasht, Guilan, Iran
City
Rasht
Postal code
Phone
+98 13 1223 6886
Fax
Email
sabouri@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Mohammad Rasoul Sabouri
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomnin Hospital, 17 Shahrivar Ave, Rasht, Guilan, Iran
City
Rasht
Postal code
Phone
+98 13 1223 6886
Fax
Email
sabouri@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
ِDr Mohammad Rasoul Sabouri
Position
Assistant Professor
Other areas of specialty/work
Street address
Amiralmomnin Hospital, 17 Shahrivar Ave, Rasht, Guilan, Iran
City
Rasht
Postal code
0098
Phone
+98 13 1223 6886
Fax
+98 13 1223 6886
Email
sabouri@gums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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