History
# Registration date Revision Id
2 2020-10-19, 1399/07/28 158942
1 2020-09-04, 1399/06/14 149496
Changes made to previous revision
  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents
  • Protocol summary

    کارآزمایی بالینی بدون گروه کنترل(تک گروهه) و بدون کورسازی بر روی 35 بیمار مبتلا به ادم ماکولای دیابتی
    کارآزمایی بالینی بدون گروه کنترل(تک گروهه) و بدون کورسازی بر روی35بیمار مبتلا به ادم ماکولای دیابتی
    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 .
    In this study, complete ophthalmology examination and OCTA are provided for 35 eyes of patients with clinically significant macular edema, Before and 1 month after intra vitreal injection of Bevacizumab (َ or stivant) . OCTA geometrical findings of FAZ area and thicknes are analyzed .
    در این مطالعه که درمانگاه چشم پزشکی پوستچی شیراز انجام می پذیرد 35 چشم از 35 بیمار تحت معاینه کامل و ا سی تی انژیوگرافی قبل و 4 هفته بعد از دریافت بواسیروماب داخل زجاجیه قرار می گیرند. سپس یافته های ا سی تی انژیوگرافی ناحیه فاز و ضخامت ماکولا و ارتباطات این اندکس ها با میزان پاسخ به درمان سنجیده می شود.
    در این مطالعه 35 چشم از بیمار ان دیابتی تحت معاینه کامل و ا سی تی انژیوگرافی قبل و یک ماه بعد از دریافت بواسیزوماب( یا استیوانت ) داخل زجاجیه قرار می گیرند. سپس یافته های ا سی تی انژیوگرافی ناحیه فاز و ضخامت ماکولا بررسی می شود.
    Inclusion criteria: patients with Diabetic macular edema. Non inclusion criteria: Myopia more than 6 diopters; laser therapy within previous 6 month; Hydroxycloroquine consumption.
    Inclusion criteria: patients with Diabetic macular edema. Exclusion criteria: Myopia more than 6 diopters; history of vitrectomy;macular hole ,CNV, Hydroxycloroquine consumption.
    معیارهای ورود: بیماران مبتلا به ماکولار ادما دیابتی. معیارهای عدم ورود: میوپی بیشتر از 6 دیوپتر؛ سابقه انجام لیزر چشم در طی 6 ماه گذشته؛ استفاده از داروهای خوراکی هیدروکسی کلروکین
    معیارهای ورود: بیماران مبتلا به ماکولار ادما دیابتی. معیارهای عدم ورود: میوپی بیشتر از 6 دیوپتر؛ سابقه انجام ویترکتومی . سوراخ ماکولا یا تحلیل شدید ماکولا و استفاده از داروهای خوراکی هیدروکسی کلروکین
    Intervention group: Patients with diabetic macular edema. These patients will receive 1.25 mg of Stivant , intravitreally.
    Intervention group: Patients with diabetic macular edema. These patients will receive 1.25 mg of Bevacizumab (or Stivant ), intravitreally by other specialist.
    گروه مداخله: بیماران مبتلا به ادم ماکولا دیابتی. این بیماران تحت درمان با 1.25 میلی گرم داروی داخل ویتره استیوانت قرار می گیرند
    گروه مداخله: بیماران مبتلا به ادم ماکولا دیابتی. این بیماران توسط متخصص دیگر تحت درمان با 1.25 میلی گرم داروی داخل ویتره بواسیزوماب ( یا استیوانت) قرار می گیرند.
  • General information

    35
    30
    70
    75
    Treatment
    Diagnostic
    35
    empty
    No
    No
    2019-01-04, 1397/10/14
    2018-06-04, 1397/03/14
    2019-07-10, 1398/04/19
    2021-07-10, 1400/04/19
    2019-01-04, 1397/10/14
    empty
    2019-07-10, 1398/04/19
    empty
    2019-09-22, 1398/06/31
    empty
    empty
    completion and correction of exclusion criteria and correction of some sentences that needs correction
    empty
    تکمیل و تصحیح شرایط خروج شرکت کنندگان و همزمان تصحیح برخی جملات و قسمتهایی که نیاز به اصلاح داشتند
    Evaluation of stivant effect on diabetic patients with macular edema
    Evaluation of Bevacizumab effect on diabetic macular edema in diabetic patients .
    بررسی اثرات استیوانت بر ادم ماکولا در بیماران دیابتی
    بررسی اثرات بواسیزوماب بر ادم ماکولا در بیماران دیابتی
    Patients with diabetic macular edema
    age between 35-70 years old
    Central macular thickness more than 300 microne based on OCT measurement
    Patients with diabetic macular edema
    age between 30-75 years old
    Central macular thickness more than 300 microne based on OCT measurement
    بیماران مبتلا به ماکولار ادما ناشی از دیابت
    گروه سنی 35 تا 70 سال
    ضخامت مرکز ماکولا بیش از 300 میکرون بر اساس اندازه گیری ا.سی.تی
    بیماران مبتلا به ماکولار ادما ناشی از دیابت
    گروه سنی 30 تا 75 سال
    ضخامت مرکز ماکولا بیش از 300 میکرون بر اساس اندازه گیری ا.سی.تی
    Myopia more than 6 diopters
    laser therapy within previous 6 month
    Hydroxycloroquine consumption
    Previous history of chemotherapy and radiotherapy
    Myopia more than 6 diopters
    other macular diseases like macular hole and CNV
    Some drugs :Hydroxycloroquine consumption
    Previous history of chemotherapy and radiotherapy
    History of vitrectomy
    میوپی بیشتر از 6 دیوپتر
    سابقه انجام لیزر چشم در طی 6 ماه گذشته
    استفاده از داروهای خوراکی هیدروکسی کلروکین
    سابقه رادیوتراپی و شیمی درمانی
    میوپی بیشتر از 6 دیوپتر
    سایر بیماریهای ماکولا مانند سوراخ ماکولا و تحلیل شدید
    استفاده از برخی داروها مانند هیدروکسی کلروکین
    سابقه رادیوتراپی و شیمی درمانی
    سابقه ویترکتومی
    In this study, we assessed pre and post features of OCT Angiography images to find vascular and morphological changes following the injection of Bevacizumab.
    In this study, we assessed features of OCT Angiography images to find vascular and morphological changes before and after the injection of Bevacizumab.
    در این مطالعه ، ما ویژگی های پیش و بعد تصاویر آنژیوگرافی OCT را برای پیدا کردن تغییرات عروقی و مورفولوژیکی پس از تزریق Bevacizumab بررسی کردیم.
    در این مطالعه ، ما ویژگی های تصاویر آنژیوگرافی OCT را برای پیدا کردن تغییرات عروقی و مورفولوژیکی قبل و بعد از تزریق Bevacizumab بررسی کردیم.
  • Intervention groups

    #1
    Treatment - Drugs
    Diagnosis
    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.
    Intervention group: ِIntravitreal injection of 1.25 mg of Bevacizumab(or stivant) will be performed by other expert in operation room under sterile condition ( for patients with diabetic macular edema). The patients will be followed before and one month after operation. In this study we did not intervene and we analyzed the OCTA images before and after what other experts injected to evaluate macular changes.
    گروه مداخله: بیماران تحت تزریق 1.25 میلی گرم بواسیزوماب در اتاق عمل درمانگاه پوستچی دانشگاه علوم پزشکی شیراز در شرایط استریل قرار میگیرند.بیماران 1 و 28 روزپس از تزریق تحت بررسی قرار می گیرند
    گروه مداخله: بیماران دیابتی مبتلا به ادم ماکولا توسط متخصص دیگر تحت تزریق 1.25 میلی گرم بواسیزوماب (یا استیوانت) داخل زجاجیه در شرایط استریل قرار میگیرند.ا سی تی انژیوگرافی بیماران قبل و یک ماه پس از تزریق تحت بررسی قرار می گیرند.
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: یونس قاسمی
    Full name of responsible person - Persian: Younes Ghasemi
    Street address - English: floor7, central bulding of shiraz university of medical sciences, zand blvd, shiraz
    Street address - Persian: شيراز - خيابان زند - جنب هلال احمر - ساختمان مركزی دانشگاه علوم پزشكی شيراز - طبقه هفتم
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 71347-14336
    Phone: +98 71 3235 7282
    Fax:
    Email: vcrdep@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Younes Ghasemi
    Full name of responsible person - Persian: یونس قاسمی
    Street address - English: Floor 7, Central bulding of Shiraz University of Medical Sciences, Zand Blvd, Shiraz
    Street address - Persian: شيراز - خيابان زند - جنب هلال احمر - ساختمان مركزی دانشگاه علوم پزشكی شيراز - طبقه هفتم
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 71347-14336
    Phone: +98 71 3235 7282
    Fax:
    Email: Vcrdep@sums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mehrdad Afarid
    Full name of responsible person - Persian: مهرداد آفرید
    Position - English: Associate Professor
    Position - Persian: استادیار
    Latest degree: sub_specialist
    Area of specialty/work: 35
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Khalili hospital ,Khalili ave, Shiraz
    Street address - Persian: شیراز- خ خلیلی- بیمارستان خلیلی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۳۳۶ - ۷۱۳۴۸
    Phone: +98 71 3629 1470
    Mobile: +98 936 073 7650
    Fax:
    Email: Mehrdad.Afarid55@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Arash ghazanfari
    Full name of responsible person - Persian: آرش غضنفری
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 35
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Unit 1, Baran building (No 169), Takestan avenue, Rajaee boulevard, Shiraz
    Street address - Persian: شیراز- بلوار شهیر رجایی - خ تاکستان- ساختمان باران 169- واحد 1
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7185955766
    Phone: 0987136333615
    Mobile: +98 917 742 9683
    Fax:
    Email: arash.ghazanfari@yahoo.com
    Web page address:
  • Sharing plan

    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    na
    undecided
    empty
    Coordination with other beneficiaries
    empty
    نیاز به هماهنگی با سایر ذینفعان
    Changes in macular thickness
    empty
    تغییرات ضخامت ماکولا
    empty
    6 month after publication
    empty
    6 ماه پس از چاپ
    empty
    Academic staff of university
    empty
    شاغلین موسسات دانشگاهی
    empty
    No need for other circumstances
    empty
    شرایط دیگری لازم نیست
    empty
    Arash.Ghazanfari@yahoo.com
    empty
    به آدرس Arash.ghazanfari@mail.com ایمیل فرستاده شود
    empty
    1 week after application, data will be sent.
    empty
    1 هفته پس از درخواست، مستندات ارسال خواهد شد
    empty

Protocol summary

Study aim
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, complete ophthalmology examination and OCTA are provided for 35 eyes of patients with clinically significant macular edema, Before and 1 month after intra vitreal injection of Bevacizumab (َ or stivant) . OCTA geometrical findings of FAZ area and thicknes are analyzed .
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with Diabetic macular edema. Exclusion criteria: Myopia more than 6 diopters; history of vitrectomy;macular hole ,CNV, Hydroxycloroquine consumption.
Intervention groups
Intervention group: Patients with diabetic macular edema. These patients will receive 1.25 mg of Bevacizumab (or Stivant ), intravitreally by other specialist.
Main outcome variables
Change in macular thickness; change in FAZ area

General information

Reason for update
completion and correction of exclusion criteria and correction of some sentences that needs correction
Acronym
IRCT registration information
IRCT registration number: IRCT20190518043622N1
Registration date: 2020-09-04, 1399/06/14
Registration timing: registered_while_recruiting

Last update: 2020-11-15, 1399/08/25
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
2018-06-04, 1397/03/14
Expected recruitment end date
2021-07-10, 1400/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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 Bevacizumab effect on diabetic macular edema in diabetic patients .
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic macular edema age between 30-75 years old Central macular thickness more than 300 microne based on OCT measurement
Exclusion criteria:
Myopia more than 6 diopters other macular diseases like macular hole and CNV Some drugs :Hydroxycloroquine consumption Previous history of chemotherapy and radiotherapy History of vitrectomy
Age
From 30 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 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 features of OCT Angiography images to find vascular and morphological changes before and after 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
Floor 7, Central building of Shiraz University of Medical Sciences, Zand street, 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(or stivant) will be performed by other expert in operation room under sterile condition ( for patients with diabetic macular edema). The patients will be followed before and one month after operation. In this study we did not intervene and we analyzed the OCTA images before and after what other experts injected to evaluate macular changes.
Category
Diagnosis

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
Younes Ghasemi
Street address
Floor 7, 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
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
0987136333615
Email
arash.ghazanfari@yahoo.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)
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
Loading...