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
The Comparison of the Efficacy of Intravitreal Injection of Iranian Made Ranibizumab (Vicentis®) with Imported Ranibizumab (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 statistical software; Sample size: 77
Settings and conduct
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.
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 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
Intervention groups
Intervention group: An intravitreal injection of 0.5 ml Ranibizumab (Aracell zist daru); Control group: An intravitreal injection of 0.5 ml Ranibizumab (Roche)
Main outcome variables
Central macular thickness
General information
Reason for update
Acronym
SVLD
IRCT registration information
IRCT registration number:IRCT20170303032845N1
Registration date:2019-02-03, 1397/11/14
Registration timing:prospective
Last update:2019-02-03, 1397/11/14
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
2019-03-06, 1397/12/15
Expected recruitment end date
2019-10-22, 1398/07/30
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 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)
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:
77
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization
Unit of Randomization: Individual
Randomization tool: Statistical software
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
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-01-08, 1397/10/18
Ethics committee reference number
IR.IUMS.REC.1397.806
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 and 90 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), 30 and 90 days after injection
Method of measurement
Snellen chart
Intervention groups
1
Description
Intervention group: An intravitreal injection of 0.5 ml Ranibizumab (Aracell zist daru)
Category
Treatment - Drugs
2
Description
Control group: An intravitreal injection of 0.5 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
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Fax
Email
s.amirpooya.alemzadeh@gmail.com
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
Mahsa Sadat Hashemian
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
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
hashemian_mahsa@yahoo.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