Protocol summary
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Study aim
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To determine changing in the OCT angiography after the Intravitreal injection of Bevacizumab in diabetic patients with clinically significant macular edema
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Design
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The trial of one group without control group, without blinding , with a sample size of 35 patients with diabetic macular edema
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Settings and conduct
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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 .
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients with Diabetic macular edema. Exclusion criteria: Myopia more than 6 diopters;
history of vitrectomy;macular hole ,CNV,
Hydroxycloroquine consumption.
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Intervention groups
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Intervention group: Patients with diabetic macular edema. These patients will receive 1.25 mg of Bevacizumab (or Stivant ), intravitreally by other specialist.
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Main outcome variables
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Change in macular thickness; change in FAZ area
General information
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Reason for update
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completion and correction of exclusion criteria and correction of some sentences that needs correction
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Acronym
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IRCT registration information
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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
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Registration date
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2020-09-04, 1399/06/14
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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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2018-06-04, 1397/03/14
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Expected recruitment end date
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2021-07-10, 1400/04/19
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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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Evaluation of the changes in the OCT angiography after the Intra Vitreal Injection of Bevacizumab in diabetic Patients with Clinically Significant Macular Edema.
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Public title
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Evaluation of Bevacizumab effect on diabetic macular edema in diabetic patients .
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Purpose
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Diagnostic
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Inclusion/Exclusion criteria
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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
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Age
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From 30 years old to 75 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
35
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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In this study, we assessed features of OCT Angiography images to find vascular and morphological changes before and after the injection of Bevacizumab.
Ethics committees
1
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Ethics committee
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Approval date
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2018-05-21, 1397/02/31
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Ethics committee reference number
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IR.SUMS.MED.REC.1397.079
Health conditions studied
1
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Description of health condition studied
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Diabetic macular edema
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ICD-10 code
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H36.0
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ICD-10 code description
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Diabetic retinopathy
Primary outcomes
1
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Description
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Change in macular thickness
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Timepoint
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Before intervention and 1 month after intervention
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Method of measurement
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Evaluation of macular thickness with OCT angiography
2
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Description
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Change in geometrical feature of FAZ area
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Timepoint
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Before intervention and 1 month after intervention
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Method of measurement
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Evaluation of geometrical features of macula with OCT angiography and analyzing it with MATLAB
Intervention groups
1
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Description
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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.
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Category
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Diagnosis
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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Shiraz University of Medical Sciences
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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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Public
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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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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be 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