Protocol summary
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Study aim
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The Comparison of the Saftey and Efficacy of Intravitreal Injection of Vicentis® with Lucentis® in Patients with Diabetic Macular Edema
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group: An intravitreal injection of 0.05 ml Ranibizumab (Aracell zist daru); Control group: An intravitreal injection of 0.05 ml Ranibizumab (Roche)
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Main outcome variables
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Central macular thickness
General information
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Reason for update
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To update the protocol and address the new site of patients recruitment
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Acronym
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SVLD
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IRCT registration information
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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
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Registration date
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2019-02-03, 1397/11/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-12-22, 1398/10/01
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Expected recruitment end date
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2021-03-19, 1399/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The Comparison of Efficacy Between Iranian Made Ranibizumab and Imported Ranibizumab in Diabetic Patients with Macular Edema
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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)
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
154
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: Block randomization
Unit of Randomization: Individual
Randomization tool: web-based software
https://www.sealedenvelope.com/simple-randomiser/v1/lists
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-08, 1397/10/18
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Ethics committee reference number
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IR.IUMS.REC.1397.806
2
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Ethics committee
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Approval date
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2020-12-29, 1399/10/09
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Ethics committee reference number
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IR.TUMS.FARABIH.REC.1399.033
Health conditions studied
1
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Description of health condition studied
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Diabetic retinopathy
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ICD-10 code
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E10.3
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ICD-10 code description
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Type 1 diabetes mellitus with ophthalmic complications
Primary outcomes
1
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Description
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Central macular thickness
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Timepoint
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At the beginning of the study (before the intervention), 30 days after injection
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Method of measurement
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Optical coherence tomography
Secondary outcomes
1
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Description
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Visual acuity
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Timepoint
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At the beginning of the study (before the intervention), 7 and 30 days after injection
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Method of measurement
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Snellen chart
Intervention groups
1
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Description
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Intervention group: An intravitreal injection of 0.05 ml Ranibizumab (Aracell zist daru)
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Category
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Treatment - Drugs
2
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Description
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Control group: An intravitreal injection of 0.05 ml Ranibizumab (Roche)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Aracell zist daru
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available