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The Comparison of the Efficacy of Intravitreal Injection of Iranian Made Ranibizumab (Vicentis®) with Imported Ranibizumab (Lucentis®) in Patients with Diabetic Macular Edema: A phase III, Two-armed, Double-blind, Parallel, Active-controlled, and Noninferiority Clinical Randomized Trial

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History
# Registration date Revision Id
2 2020-09-05, 1399/06/15 167905
1 2019-02-03, 1397/11/14 77947
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  • Protocol summary

    The Comparison of the Efficacy of Intravitreal Injection of Iranian Made Ranibizumab (Vicentis®) with Imported Ranibizumab (Lucentis®) in Patients with Diabetic Macular Edema
    The Comparison of the Saftey and Efficacy of Intravitreal Injection of Vicentis® with Lucentis® in Patients with Diabetic Macular Edema
    A phase III, two-armed, double-blind, parallel, active-controlled, and non-inferiority clinical randomized trial; Randomization method: Block, Individual, by use of statistical software; Sample size: 77
    A phase III, two-armed, double-blind, parallel, active-controlled, and non-inferiority clinical randomized trial; Randomization method: Block, Individual, by use of web-based software; Sample size: 154
    کارآزمایی بالینی فاز سه، تصادفی سازی شده، دو بازویی، دو سو کور (بیمار و ارزیابی کننده)، موازی، کنترل فعال و non-inferiority؛ نحوه تصادفی سازی: تصادفی سازی بلوک، فردی، با استفاده از نرم افزار آماری؛ حجم نمونه پیش‌بینی شده: ۷۷
    کارآزمایی بالینی فاز سه، تصادفی سازی شده، دو بازویی، دو سو کور (بیمار و ارزیابی کننده)، موازی، کنترل فعال و non-inferiority؛ نحوه تصادفی سازی: تصادفی سازی بلوک، فردی، با استفاده از نرم افزار اینترنتی ؛ حجم نمونه پیش‌بینی شده: 154
    77 patients with diabetes mellitus referring to Rassoul Akram hospital eye clinic will be included in the study. Patients will be randomized into one of the following groups: Ranibizumab (Visentis) or Ranibizumab (Lucentis). Both drugs are indistinguishable for patients and the medical staff, and the only informed person is the nurse who is responsible for preparing the Ranibizumab. Additionally, people who evaluate the results and analyze data are not aware of the patients' group assignments. After intravitreal injection of ranibizumab, the variables will be evaluated at intervals of 1 and 3 months.
    154 patients with diabetes mellitus referring to Rassoul Akram hospital eye clinic will be included in the study. Patients will be randomized into one of the following groups: Ranibizumab (Visentis) or Ranibizumab (Lucentis). Both drugs are indistinguishable for patients and the medical staff, and the only informed person is the nurse who is responsible for preparing the Ranibizumab. Additionally, people who evaluate the results and analyze data are not aware of the patients' group assignments. After intravitreal injection of ranibizumab, the variables will be evaluated at intervals of 1 month.
    ۷۷ بیمار مبتلا به ادم ماکولای دیابتی که به درمانگاه چشم بیمارستان رسول اکرم (ص) مراجعه کرده اند، وارد مطالعه خواهند شد. بیماران بر اساس روش تصادفی سازی در یکی از دو گروه رانیبیزومب (ویسنتیس) و یا رانیبیزومب (لوسنتیس) قرار می گیرند. هر دو دارو، برای بیماران و کادر درمانی مربوطه غیر قابل تشخیص بوده و تنها فرد مطلع، پرستار مسئول آماده سازی رانیبیزومب می باشد. علاوه بر این، افرادی که بررسی نتایج و آنالیز داده ها را انجام می دهند، از نوع گروه بیماران آگاهی ندارند. پس از تزریق داخل چشمی رانیبیزومب، متغیرهای مربوطه در فواصل ۱ و ۳ ماهه ارزیابی می شوند.
    154 بیمار مبتلا به ادم ماکولای دیابتی که به درمانگاه چشم بیمارستان رسول اکرم (ص) مراجعه کرده اند، وارد مطالعه خواهند شد. بیماران بر اساس روش تصادفی سازی در یکی از دو گروه رانیبیزومب (ویسنتیس) و یا رانیبیزومب (لوسنتیس) قرار می گیرند. هر دو دارو، برای بیماران و کادر درمانی مربوطه غیر قابل تشخیص بوده و تنها فرد مطلع، پرستار مسئول آماده سازی رانیبیزومب می باشد. علاوه بر این، افرادی که بررسی نتایج و آنالیز داده ها را انجام می دهند، از نوع گروه بیماران آگاهی ندارند. پس از تزریق داخل چشمی رانیبیزومب، متغیرهای مربوطه در فاصل ۱ ماهه ارزیابی می شوند.
    Inclusion criteria: Age between 18 to 80 years old; Diabetes mellitus type 1 or 2; Center involving macular edema with a central subfield thickness of >300; Early treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity letter score of 24 to 78 (20/32 to 20/400); Signed written inform consent; Exclusion criteria: History of intravitreal injection, ocular surgery, glaucoma or ocular hypertension; Any media opacity; Monocular patients; Proliferative diabetic retinopathy with high-risk characteristics; HbA1c>10%; Use of IOP-lowering drops, systemic corticosteroids or nonsteroidal anti-inflammatory eye drops
    Inclusion criteria: Age between 18 to 80 years old; Diabetes mellitus type 1 or 2; Center involving macular edema with a central subfield thickness of >300; Early treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity letter score of 24 to 78 (20/32 to 20/400); Signed written informed consent; Exclusion criteria: History of intravitreal injection within 2 months ago, ocular surgery, glaucoma or ocular hypertension; Any media opacity; Monocular patients; Proliferative diabetic retinopathy with high-risk characteristics; HbA1c>10%; Use of IOP-lowering drops, systemic corticosteroids or nonsteroidal anti-inflammatory eye drops
    شرایط ورود به مطالعه: سنین بالای ۱۸ سال و پایین تر از ۸۰ سال؛ ابتلا به دیابت نوع ۱ و یا ۲؛ مبتلا به ادم ماکولای دیابتی با ضخامت مرکزی ماکولای بالای ۳۰۰ میکرون؛ حدت بینایی بین ۲۰/۳۲ تا ۲۰/۴۰۰ (۲۴ تا ۷۸ خط ETDRS)؛ امضای فرم رضایت نامه آگاهانه؛ شرایط عدم ورود به مطالعه: سابقه تزریق داخلی چشمی، هرگونه عمل جراحی چشمی، بیماری گلوکوم و یا افزایش فشار چشم؛ هر نوع کدورت محیط شفاف چشم؛ بیماران تک چشمی؛ رتینوپاتی دیابتی پرولیفراتیو پیشرفته با احتمال خطر بالا؛ HbA1c بیشتر از ۱۰ درصد؛ مصرف قطره های کاهنده فشار داخل چشم، کورتیکواستروئیدهای سیستمیک و یا قطره های چشمی ضد التهاب غیر استروئیدی
    شرایط ورود به مطالعه: سنین بالای ۱۸ سال و پایین تر از ۸۰ سال؛ ابتلا به دیابت نوع ۱ و یا ۲؛ مبتلا به ادم ماکولای دیابتی با ضخامت مرکزی ماکولای بالای ۳۰۰ میکرون؛ حدت بینایی بین ۲۰/۳۲ تا ۲۰/۴۰۰ (۲۴ تا ۷۸ خط ETDRS)؛ امضای فرم رضایت نامه آگاهانه؛ شرایط عدم ورود به مطالعه: سابقه تزریق داخلی چشمی در 2 ماه گدشته ، هرگونه عمل جراحی چشمی، بیماری گلوکوم و یا افزایش فشار چشم؛ هر نوع کدورت محیط شفاف چشم؛ بیماران تک چشمی؛ رتینوپاتی دیابتی پرولیفراتیو پیشرفته با احتمال خطر بالا؛ HbA1c بیشتر از ۱۰ درصد؛ مصرف قطره های کاهنده فشار داخل چشم، کورتیکواستروئیدهای سیستمیک و یا قطره های چشمی ضد التهاب غیر استروئیدی
    Intervention group: An intravitreal injection of 0.5 ml Ranibizumab (Aracell zist daru); Control group: An intravitreal injection of 0.5 ml Ranibizumab (Roche)
    Intervention group: An intravitreal injection of 0.05 ml Ranibizumab (Aracell zist daru); Control group: An intravitreal injection of 0.05 ml Ranibizumab (Roche)
    گروه مداخله: یکبار تزریق داخل چشمی ۰.۵ میلی لیتر از رانیبیزومب شرکت آراسل زیست دارو؛ گروه کنترل: یکبار تزریق داخل چشمی ۰.۵ میلی لیتر از رانیبیزومب شرکت روش
    گروه مداخله: یکبار تزریق داخل چشمی 0.05 میلی لیتر از رانیبیزومب شرکت آراسل زیست دارو؛ گروه کنترل: یکبار تزریق داخل چشمی 0.05 میلی لیتر از رانیبیزومب شرکت روش

  • General information

    77
    154
    2019-03-06, 1397/12/15
    2019-12-22, 1398/10/01
    2019-10-22, 1398/07/30
    2021-03-19, 1399/12/29
    empty
    To update the protocol and address the new site of patients recruitment
    empty
    بعلت بروزرسانی در پروتوکل و همچنین اضافه شده سایت جدید بیمارگیری
    History of intravitreal injection within the past 3 months
    History of any ocular surgery within the past 6 months
    History of glaucoma or ocular hypertension
    Any media opacity in the cornea, lens and vitreous body which interferes with eye examination and imaging.
    Monocular patients
    Pregnant or breastfeeding women
    Proliferative diabetic retinopathy (PDR) with high-risk characteristics
    HbA1c>10%
    Smoking (more than 10 cigarettes per day)
    Use of acetazolamide tablets or intraocular pressure-lowering drops
    Use of systemic corticosteroids or nonsteroidal anti-inflammatory eye drops (NSAIDs)
    History of intravitreal injection within the past 2 months
    History of any ocular surgery within the past 6 months
    History of glaucoma or ocular hypertension
    Any media opacity in the cornea, lens and vitreous body which interferes with eye examination and imaging.
    Monocular patients
    Pregnant or breastfeeding women
    Proliferative diabetic retinopathy (PDR) with high-risk characteristics
    HbA1c>10%
    Smoking (more than 10 cigarettes per day)
    Use of acetazolamide tablets or intraocular pressure-lowering drops
    Use of systemic corticosteroids or nonsteroidal anti-inflammatory eye drops (NSAIDs)
    سابقه تزریق داخلی چشمی در ۳ ماه گذشته
    سابقه هرگونه عمل جراحی چشمی در ۶ ماه گذشته
    سابقه بیماری گلوکوم و یا افزایش فشار چشم
    هر نوع کدورت محیط شفاف چشم مانند کدروت قرنیه، عدسی و زجاجیه در حدی که معاینه و انجام تصویربرداری را مختل نماید.
    بیماران تک چشمی
    خانم های باردار و یا شیرده
    رتینوپاتی دیابتی پرولیفراتیو پیشرفته با احتمال خطر بالا
    HbA1c بیشتر از ۱۰ درصد
    سیگار کشیدن (بیش از ۱۰ نخ سیگار در روز)
    مصرف قرص استازولامید و یا قطره های کاهنده فشار داخل چشم
    مصرف کورتیکواستروئید سیستمیک یا قطره های چشمی ضد التهاب غیر استروئیدی
    سابقه تزریق داخلی چشمی در 2 ماه گذشته
    سابقه هرگونه عمل جراحی چشمی در ۶ ماه گذشته
    سابقه بیماری گلوکوم و یا افزایش فشار چشم
    هر نوع کدورت محیط شفاف چشم مانند کدروت قرنیه، عدسی و زجاجیه در حدی که معاینه و انجام تصویربرداری را مختل نماید.
    بیماران تک چشمی
    خانم های باردار و یا شیرده
    رتینوپاتی دیابتی پرولیفراتیو پیشرفته با احتمال خطر بالا
    HbA1c بیشتر از ۱۰ درصد
    سیگار کشیدن (بیش از ۱۰ نخ سیگار در روز)
    مصرف قرص استازولامید و یا قطره های کاهنده فشار داخل چشم
    مصرف کورتیکواستروئید سیستمیک یا قطره های چشمی ضد التهاب غیر استروئیدی
    Randomization method: Block randomization Unit of Randomization: Individual Randomization tool: Statistical software
    Randomization method: Block randomization Unit of Randomization: Individual Randomization tool: web-based software https://www.sealedenvelope.com/simple-randomiser/v1/lists
    روش تصادفی سازی: تصادفی سازی بلوک واحد تصادفی سازی: فردی ابزار تصادفی سازی: نرم افزار آماری
    روش تصادفی سازی: تصادفی سازی بلوک واحد تصادفی سازی: فردی ابزار تصادفی سازی: نرم افزار اینترنتی https://www.sealedenvelope.com/simple-randomiser/v1/lists

  • Ethics committees

    #1
    empty
    2020-12-29, 1399/10/09
    empty
    IR.TUMS.FARABIH.REC.1399.033

  • Primary outcomes

    #1
    At the beginning of the study (before the intervention), 30 and 90 days after injection
    At the beginning of the study (before the intervention), 30 days after injection
    در ابتدای مطالعه (قبل از شروع مداخله)، ۳۰ و ۹۰ روز بعد از تزریق
    در ابتدای مطالعه (قبل از شروع مداخله)، ۳۰ روز بعد از تزریق

  • Secondary outcomes

    #1
    At the beginning of the study (before the intervention), 30 and 90 days after injection
    At the beginning of the study (before the intervention), 7 and 30 days after injection
    در ابتدای مطالعه (قبل از شروع مداخله)، ۳۰ و ۹۰ روز بعد از تزریق
    در ابتدای مطالعه (قبل از شروع مداخله)، هفت و ۳۰ روز بعد از تزریق

  • Intervention groups

    #1
    Intervention group: An intravitreal injection of 0.5 ml Ranibizumab (Aracell zist daru)
    Intervention group: An intravitreal injection of 0.05 ml Ranibizumab (Aracell zist daru)
    گروه مداخله: یکبار تزریق داخل چشمی ۰.۵ میلی لیتر از رانیبیزومب شرکت آراسل زیست دارو
    گروه مداخله: یکبار تزریق داخل چشمی 0.05 میلی لیتر از رانیبیزومب شرکت آراسل زیست دارو
    #2
    Control group: An intravitreal injection of 0.5 ml Ranibizumab (Roche)
    Control group: An intravitreal injection of 0.05 ml Ranibizumab (Roche)
    گروه کنترل: یکبار تزریق داخل چشمی ۰.۵ میلی لیتر از رانیبیزومب شرکت روش
    گروه کنترل: یکبار تزریق داخل چشمی 0.05 میلی لیتر از رانیبیزومب شرکت روش

  • Recruitment centers

    #1
    Name of recruitment center - English: Rassoul Akram hospital
    Name of recruitment center - Persian: مجتمع آموزشي و پژوهشي و درماني حضرت رسول اكرم (ص)
    Full name of responsible person - English: Sayyed Amirpooya Alemzadeh
    Full name of responsible person - Persian: سید امیر پویا عالم زاده
    Street address - English: Rassoul Akram Hospital, Sattarkhan-Niayesh St.
    Street address - Persian: خيابان ستارخان، خيابان نيايش، مجتمع آموزشي و پژوهشي و درماني حضرت رسول اكرم (ص)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1445613131
    Phone: +98 21 6655 8811
    Fax:
    Email: s.amirpooya.alemzadeh@gmail.com
    Web page address:
    Name of recruitment center - English: Rassoul Akram hospital
    Name of recruitment center - Persian: مجتمع آموزشي و پژوهشي و درماني حضرت رسول اكرم (ص)
    Full name of responsible person - English: Sayyed Amirpooya Alemzadeh
    Full name of responsible person - Persian: سید امیر پویا عالم زاده
    Street address - English: Rassoul Akram Hospital, Sattarkhan-Niayesh St.
    Street address - Persian: خيابان ستارخان، خيابان نيايش، مجتمع آموزشي و پژوهشي و درماني حضرت رسول اكرم (ص)
    City - English: تهران
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1445613131
    Phone: +98 21 6655 8811
    Fax:
    Email: sapab.me@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: Farabi Hospital
    Name of recruitment center - Persian: بیمارستان فارابی
    Full name of responsible person - English: Nazanin Ebrahimi Adib
    Full name of responsible person - Persian: نازنین ابراهیمی ادیب
    Street address - English: South Kargar St, Qazvin Square
    Street address - Persian: خیابان کارگر جنوبی میدان قزوین
    City - English: Tehran
    City - Persian: Tehran
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۳۳۶۶۱۶۳۵۱
    Phone: +98 21 5540 0003
    Fax:
    Email: nazanin.ebrahimiadib@gmail.com
    Web page address: http://farabih.tums.ac.ir/

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mahsa Sadat Hashemian
    Full name of responsible person - Persian: مهسا سادات هاشمیان
    Position - English: Research assistant
    Position - Persian: دستیار پژوهشی
    Latest degree: med_doctor
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Iran Eye Research Center, Rassoul Akram Hospital, Sattarkhan-Niayesh St.
    Street address - Persian: خيابان ستارخان، خيابان نيايش، مجتمع آموزشي و پژوهشي و درماني حضرت رسول اكرم (ص)، ساختمان سيد الشهداء، طبقه ۸، مركز تحقيقات چشم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1445613131
    Phone: +98 21 6651 6999
    Mobile: +98 912 445 4975
    Fax:
    Email: hashemian_mahsa@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sayyed Amirpooya Alemzadeh
    Full name of responsible person - Persian: سیدامیرپویا عالم زاده
    Position - English: Clinician scientist resident
    Position - Persian: دستیار پزشک پژوهشگر
    Latest degree: med_doctor
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Iran Eye Research Center, Rassoul Akram Hospital, Sattarkhan-Niayesh St.
    Street address - Persian: خيابان ستارخان، خيابان نيايش، مجتمع آموزشي و پژوهشي و درماني حضرت رسول اكرم (ص)، ساختمان سيد الشهداء، طبقه ۸، مركز تحقيقات چشم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1445613131
    Phone: +98 21 6651 6999
    Mobile: +98 912 480 5708
    Fax:
    Email: s.amirpooy.alemzadeh@gmail.com
    Web page address:

Protocol summary

Study aim
The Comparison of the Saftey and Efficacy of Intravitreal Injection of Vicentis® with Lucentis® in Patients with Diabetic Macular Edema
Design
A phase III, two-armed, double-blind, parallel, active-controlled, and non-inferiority clinical randomized trial; Randomization method: Block, Individual, by use of web-based software; Sample size: 154
Settings and conduct
154 patients with diabetes mellitus referring to Rassoul Akram hospital eye clinic will be included in the study. Patients will be randomized into one of the following groups: Ranibizumab (Visentis) or Ranibizumab (Lucentis). Both drugs are indistinguishable for patients and the medical staff, and the only informed person is the nurse who is responsible for preparing the Ranibizumab. Additionally, people who evaluate the results and analyze data are not aware of the patients' group assignments. After intravitreal injection of ranibizumab, the variables will be evaluated at intervals of 1 month.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 to 80 years old; Diabetes mellitus type 1 or 2; Center involving macular edema with a central subfield thickness of >300; Early treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity letter score of 24 to 78 (20/32 to 20/400); Signed written informed consent; Exclusion criteria: History of intravitreal injection within 2 months ago, ocular surgery, glaucoma or ocular hypertension; Any media opacity; Monocular patients; Proliferative diabetic retinopathy with high-risk characteristics; HbA1c>10%; Use of IOP-lowering drops, systemic corticosteroids or nonsteroidal anti-inflammatory eye drops
Intervention groups
Intervention group: An intravitreal injection of 0.05 ml Ranibizumab (Aracell zist daru); Control group: An intravitreal injection of 0.05 ml Ranibizumab (Roche)
Main outcome variables
Central macular thickness

General information

Reason for update
To update the protocol and address the new site of patients recruitment
Acronym
SVLD
IRCT registration information
IRCT registration number: IRCT20170303032845N1
Registration date: 2019-02-03, 1397/11/14
Registration timing: prospective

Last update: 2021-01-19, 1399/10/30
Update count: 1
Registration date
2019-02-03, 1397/11/14
Registrant information
Name
Mehdi Modarreszadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 8811
Email address
modarreszadeh.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Efficacy of Intravitreal Injection of Iranian Made Ranibizumab (Vicentis®) with Imported Ranibizumab (Lucentis®) in Patients with Diabetic Macular Edema: A phase III, Two-armed, Double-blind, Parallel, Active-controlled, and Noninferiority Clinical Randomized Trial
Public title
The Comparison of Efficacy Between Iranian Made Ranibizumab and Imported Ranibizumab in Diabetic Patients with Macular Edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes mellitus type 1 or 2 Center involving macular edema with a central subfield thickness (CST) of >300 Early treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity letter score of 24 to 78 (20/32 to 20/400) HbA1c<9% Blood Pressure <150/100 Triglyceride and LDL up to 20% higher than upper normal limits Pseudophakic patients are allowed to enter the study. Signed written inform consent
Exclusion criteria:
History of intravitreal injection within the past 2 months History of any ocular surgery within the past 6 months History of glaucoma or ocular hypertension Any media opacity in the cornea, lens and vitreous body which interferes with eye examination and imaging. Monocular patients Pregnant or breastfeeding women Proliferative diabetic retinopathy (PDR) with high-risk characteristics HbA1c>10% Smoking (more than 10 cigarettes per day) Use of acetazolamide tablets or intraocular pressure-lowering drops Use of systemic corticosteroids or nonsteroidal anti-inflammatory eye drops (NSAIDs)
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 154
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization Unit of Randomization: Individual Randomization tool: web-based software https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
Both Ranibizumab drugs are indistinguishable for patients and the medical staff, and the only informed person is the nurse who is responsible for preparing the Ranibizumab according to the physician's instructions. Since Ranibizumab route of administration is intravitreal injection, it is possible to blind patients to the treatment groups. Additionally, people who evaluate the results and analyze data are not aware of the patients' group assignments.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
تهران
Province
Tehran
Postal code
1449614535
Approval date
2019-01-08, 1397/10/18
Ethics committee reference number
IR.IUMS.REC.1397.806

2

Ethics committee
Name of ethics committee
Farabi Eye Hospital- Tehran University of Medical Sciences
Street address
The south Kargar St, Qazvin Square
City
Tehran
Province
Tehran
Postal code
۱۳۳۶۶۱۶۳۵۱
Approval date
2020-12-29, 1399/10/09
Ethics committee reference number
IR.TUMS.FARABIH.REC.1399.033

Health conditions studied

1

Description of health condition studied
Diabetic retinopathy
ICD-10 code
E10.3
ICD-10 code description
Type 1 diabetes mellitus with ophthalmic complications

Primary outcomes

1

Description
Central macular thickness
Timepoint
At the beginning of the study (before the intervention), 30 days after injection
Method of measurement
Optical coherence tomography

Secondary outcomes

1

Description
Visual acuity
Timepoint
At the beginning of the study (before the intervention), 7 and 30 days after injection
Method of measurement
Snellen chart

Intervention groups

1

Description
Intervention group: An intravitreal injection of 0.05 ml Ranibizumab (Aracell zist daru)
Category
Treatment - Drugs

2

Description
Control group: An intravitreal injection of 0.05 ml Ranibizumab (Roche)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rassoul Akram hospital
Full name of responsible person
Sayyed Amirpooya Alemzadeh
Street address
Rassoul Akram Hospital, Sattarkhan-Niayesh St.
City
تهران
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Fax
Email
sapab.me@gmail.com

2

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Nazanin Ebrahimi Adib
Street address
South Kargar St, Qazvin Square
City
Tehran
Province
Tehran
Postal code
۱۳۳۶۶۱۶۳۵۱
Phone
+98 21 5540 0003
Email
nazanin.ebrahimiadib@gmail.com
Web page address
http://farabih.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Aracell zist daru
Full name of responsible person
Mohsen Nayebpour
Street address
Pharmaceutical Incubator Center, No. 1462, North Kargar St.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8857 6085
Email
info@ara-cell.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aracell zist daru
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sayyed Amirpooya Alemzadeh
Position
Clinician scientist resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Iran Eye Research Center, Rassoul Akram Hospital, Sattarkhan-Niayesh St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Fax
Email
s.amirpooya.alemzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Modarreszadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Iran Eye Research Center, Rassoul Akram Hospital, Sattarkhan-Niayesh St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Fax
Email
mmodarres51@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sayyed Amirpooya Alemzadeh
Position
Clinician scientist resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Iran Eye Research Center, Rassoul Akram Hospital, Sattarkhan-Niayesh St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 6999
Fax
Email
s.amirpooy.alemzadeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
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
No - There is not 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
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