Determining the association of response rate to Intravitreal injection of bevacizumab and macular vessel density in patients with diabetic macular edema using optical coherence tomography angiography (OCT-A) in outpatients referred to Feyz Hospital
Determining the association of response rate to Intravitreal injection of bevacizumab and macular vessel density in patients with diabetic macular edema using optical coherence tomography angiography (OCT-A)
Design
First, their information was recorded, then OCT-A is taken from both eyes in 3 * 3 mm slabs (to eliminate Projection Artifact, the slabs have been changed from 6 * 6 to 3 * 3 mm) and the amount Vascular density in the superficial and deep layers in the Superior And Inferior Hemifeild in the macular and paraphute regions is determined. 3-4 mm apart from the limbus is done by intravitreal injection and these injections are continued up to three times a month. Finally, one month after the last injection, OCT-A was taken again.
Settings and conduct
The aim of this study was to evaluate the response to internal vitreous injection of vascular endothelium growth factor inhibitors based on vascular density in outpatient diabetic patients referred to Feyz Hospital with non-proliferative retinopathy with diabetic macular edema with inclusion criteria from which OCT is obtained.
Participants/Inclusion and exclusion criteria
The present study is a longitudinal study with a pre-post design.Samples are selected based on inclusion criteria and OCT is taken from them. Women with a central macular thickness (CMT) above 305 μm and men a CMT above 320 μm were included in the study.
Intervention groups
Samples have non-proliferative diabetic retinopathy with diabetic macular edema that were included in the study based on inclusion criteria.
Main outcome variables
the vascular density in the superficial and deep layers was examined and compared before and after the injection. a 10% reduction in CMT was considered to be an appropriate level of response to treatment. The used imaging system in our study was RTVue XR Avanti (Optovue Inc., Fremont, CA, USA).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220416054548N1
Registration date:2022-05-23, 1401/03/02
Registration timing:registered_while_recruiting
Last update:2022-05-23, 1401/03/02
Update count:0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Mahya ghazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
ghazyzeynab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the association of response rate to Intravitreal injection of bevacizumab and macular vessel density in patients with diabetic macular edema using optical coherence tomography angiography (OCT-A) in outpatients referred to Feyz Hospital
Public title
Determining the association of response rate to Intravitreal injection of bevacizumab and macular vessel density in patients with diabetic macular edema using optical coherence tomography angiography (OCT-A)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Having type 1 or 2 diabetes
Central macular edema based on Heidelberg's clinical examination and OCT in one or both eyes (at least 305 μm in women and 320 μm in men)
Best modified view less than or equal to 10/7
No history of laser in the patient's eye
Moderate to severe non-proliferative diabetic retinopathy with diabetic macular edema
Transparent media to the extent that it does not interfere with the quality of images and their analysis (SSI: signal strength index: 37-40)
Exclusion criteria:
History of retinal vascular obstructive diseases
History of intraocular injection in the last 6 months
History of intraocular and retinal laser in the affected eye in the last 12 months
Decreased vision following any ocular pathology other than diabetic retinopathy
High Myopia (≥ -8)
History of eye surgery in the last 6 months
Uncontrolled glaucoma (IOP ≥ 30 mmHg despite maximal treatment)
Uncontrolled diabetes
Uncontrolled blood pressure (SBP ≥180 mmHg or DBP ≥100 mmHg
Connective tissue diseases
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-12-10, 1400/09/19
Ethics committee reference number
IR.MUI.MED.REC.1400.682
Health conditions studied
1
Description of health condition studied
Determining the association of response rate to Intravitreal injection of bevacizumab and macular vessel density in patients with diabetic macular edema using optical coherence tomography angiography (OCT-A) in outpatients referred to Feyz Hospital
ICD-10 code
E08.321
ICD-10 code description
Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema
Primary outcomes
1
Description
Blood sugar levels
Timepoint
Before the intervention
Method of measurement
blood test
2
Description
blood pressure
Timepoint
Before the intervention
Method of measurement
Physical examination
3
Description
Severity of retinopathy
Timepoint
Before the intervention
Method of measurement
Examination with slit lamp
4
Description
The best modified vision
Timepoint
Before the intervention
Method of measurement
Physical examination
5
Description
Eye pressure
Timepoint
Before the intervention
Method of measurement
Measurement with tonometer
6
Description
The central thickness of the macula
Timepoint
Before the intervention and 1 month after the last injection
Method of measurement
OCT
7
Description
FAZ level
Timepoint
Before the intervention and 1 month after the last injection
Method of measurement
OCT-A
8
Description
Vascular density of the surface layer
Timepoint
Before the intervention and 1 month after the last injection
Method of measurement
OCT-A
9
Description
Deep layer vascular density
Timepoint
Before the intervention and 1 month after the last injection
Method of measurement
OCT-A
10
Description
Total vascular density
Timepoint
Before the intervention and 1 month after the last injection
Method of measurement
OCT-A
Secondary outcomes
1
Description
The central thickness of the macula
Timepoint
One month after the last injection
Method of measurement
OCT
2
Description
FAZ level
Timepoint
One month after the last injection
Method of measurement
OCT-A
3
Description
Vascular density of the surface layer
Timepoint
One month after the last injection
Method of measurement
OCT-A
4
Description
Deep layer vascular density
Timepoint
One month after the last injection
Method of measurement
OCT-A
5
Description
Total vascular density
Timepoint
One month after the last injection
Method of measurement
OCT-A
Intervention groups
1
Description
Intervention group: The present study is a longitudinal study with a pre-post design. Samples are selected sequentially from outpatients to ophthalmology clinics who have non-proliferative diabetic retinopathy with diabetic macular edema based on inclusion criteria and OCT is taken from them. Women with a central macular thickness (CMT) above 305 μm and men a CMT above 320 μm were included in the study. First, comprehensive examinations were performed on the patients and their information was recorded. After that OCT-A images was taken from both eyes of the patients in 3 × 3 mm slabs (to remove projection artifacts, the slabs were changed 6 × 6 mm to 3 × 3 mm). The level of vascular density was determined in the superficial and deep layers and superior and inferior hemifield defects were determined in the macular and parachute areas. After that, the patients who were candidates for treatment based on the standard protocols of diabetic macular edema (DME) treatment, in a sterile organized environment, 1.25 mg of bevacizumbe was injected intravenously with a distance of 3–4 mm from the limbus. For any of patients, the injections were continued up to three times every month. Finally, one month after the last injection, OCT-A scan was taken again and the vascular density in the superficial and deep layers was examined and compared before and after the injection. In this study, a 10% reduction in CMT was considered to be an appropriate level of response to treatment. The used imaging system in our study was RTVue XR Avanti (Optovue Inc., Fremont, CA, USA).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Educational Therapeutic Center
Full name of responsible person
Mahya Qazi
Street address
Feyz Educational and Medical Center, at the beginning of Modares St., Ghods Square.
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3445 2033
Email
research@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
siavash@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahya Ghazi
Position
Ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
Email
ghazyzeynab@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahya Ghazi
Position
Ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
Email
ghazyzeynab@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahya Ghazi
Position
Ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
Email
ghazyzeynab@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available