Evaluation of the changes in the OCT angiography after the Intra Vitreal Injection of Bevacizumab in diabetic Patients with Clinically Significant Macular Edema.
To determine changing in the OCT angiography after the Intravitreal injection of Bevacizumab in diabetic patients with clinically significant macular edema
Design
The trial of one group without control group, without blinding , with a sample size of 35 patients with diabetic macular edema
Settings and conduct
In this study, which is conducted at Shiraz Poostchi ophtalmology clinic, complete ophthalmology examination and OCTA are provided for 35 eyes of 35 diabetic patients with clinically significant macular edema, Before and 4 weeks after intra vitreal injection of Bevacizumab. OCTA geometrical findings of FAZ area and thickness and correlation of these indices with response to therapy are analyzed .
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with Diabetic macular edema. Non inclusion criteria: Myopia more than 6 diopters;
laser therapy within previous 6 month;
Hydroxycloroquine consumption.
Intervention groups
Intervention group: Patients with diabetic macular edema. These patients will receive 1.25 mg of Stivant , intravitreally.
Main outcome variables
Change in macular thickness; change in FAZ area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190518043622N1
Registration date:2020-09-04, 1399/06/14
Registration timing:retrospective
Last update:2020-09-04, 1399/06/14
Update count:1
Registration date
2020-09-04, 1399/06/14
Registrant information
Name
Arash ghazanfari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3633 3615
Email address
arash.ghazanfari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-04, 1397/10/14
Expected recruitment end date
2019-07-10, 1398/04/19
Actual recruitment start date
2019-01-04, 1397/10/14
Actual recruitment end date
2019-07-10, 1398/04/19
Trial completion date
2019-09-22, 1398/06/31
Scientific title
Evaluation of the changes in the OCT angiography after the Intra Vitreal Injection of Bevacizumab in diabetic Patients with Clinically Significant Macular Edema.
Public title
Evaluation of stivant effect on diabetic patients with macular edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic macular edema
age between 35-70 years old
Central macular thickness more than 300 microne based on OCT measurement
Exclusion criteria:
Myopia more than 6 diopters
laser therapy within previous 6 month
Hydroxycloroquine consumption
Previous history of chemotherapy and radiotherapy
Age
From 35 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
35
Actual sample size reached:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In this study, we assessed pre and post features of OCT Angiography images to find vascular and morphological changes following the injection of Bevacizumab.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Floor7, central building of shiraz university of medical sciences, zand Blv,shiraz
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2018-05-21, 1397/02/31
Ethics committee reference number
IR.SUMS.MED.REC.1397.079
Health conditions studied
1
Description of health condition studied
Diabetic macular edema
ICD-10 code
H36.0
ICD-10 code description
Diabetic retinopathy
Primary outcomes
1
Description
Change in macular thickness
Timepoint
Before intervention and 1 month after intervention
Method of measurement
Evaluation of macular thickness with OCT angiography
2
Description
Change in geometrical feature of FAZ area
Timepoint
Before intervention and 1 month after intervention
Method of measurement
Evaluation of geometrical features of macula with OCT angiography and analyzing it with MATLAB
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravitreal injection of 1.25 mg of Bevacizumab will be performed in operation room of Poostchi eye clinic of Shiraz University of Medical Sciences under sterile condition. The patients will be followed 1 and 28 days after operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Postchi Ophthalmology Center
Full name of responsible person
Mohammad Hosein Norooz zade
Street address
Ophthalmology Clinic of Poostchi , Zand Boulevard, Shiraz
City
shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3230 2830
Email
poostchi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
یونس قاسمی
Street address
floor7, central bulding of shiraz university of medical sciences, zand blvd, shiraz
City
shiraz
Province
Fars
Postal code
71347-14336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Arash Ghazanfari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Unit 1, Baran building (No 169), Takestan avenue, Rajaee boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
7185955766
Phone
+98 71 3633 3615
Email
Arash.ghazanfari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Afarid
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khalili hospital ,Khalili ave, Shiraz
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3629 1470
Email
Mehrdad.Afarid55@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Arash Ghazanfari
Position
Resident of ophtalmology
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Unit 1, Baran building (No 169), Takestan avenue, Rajaee boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
7185955766
Phone
+98 71 3633 3615
Fax
Email
arash.ghazanfari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Changes in macular thickness
When the data will become available and for how long
6 month after publication
To whom data/document is available
Academic staff of university
Under which criteria data/document could be used
No need for other circumstances
From where data/document is obtainable
Arash.Ghazanfari@yahoo.com
What processes are involved for a request to access data/document