Evaluation of the effect of Interferon Alfa-2b in combination with intra-vitreal injection of Bevacizumab in the treatment of diabetic macular edema: a randomized double-blinded clinical trial
Evaluation of the effect of Interferon Alfa-2b in combination with intra-vitreal injection of Bevacizumab in the treatment of diabetic macular edema:
a randomized double-blinded clinical trial
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 49 patients.
Settings and conduct
In this study, diabetic patients referred to the retina clinic of Torfeh Hospital in Tehran, are examined within the specified time interval .Only one eye from each patient is included in the study.
For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed at one-month intervals. In the first group, interferon 2b α drops (1 MU/Ml) start immediately after the first injection, and patients use one drop every 6 hours in the affected eye for three months. In the second group, placebo (artificial tears) is prescribed for patients.
Participants/Inclusion and exclusion criteria
Diabetic patients over 18 years old; Macular edema involving the center; BCVA between 20/400-40/20; The central thickness of the macula is greater than or equal to 300 μm; Requires 3 IVB injections in the next 12 weeks; Retinal clarity; pupil dilation for OCT; necessary cooperation for proper fundus photography
Intervention groups
The control group will be treated with bevacizumab and artificial tear drops
The treatment group will be treated with bevacizumab and interferon alpha 2b
Main outcome variables
Best corrected visual acuity (BCVA) in patients; Central macular thickness in OCT in patients; intraocular pressure in these patients;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230103057035N1
Registration date:2023-03-18, 1401/12/27
Registration timing:registered_while_recruiting
Last update:2023-03-18, 1401/12/27
Update count:0
Registration date
2023-03-18, 1401/12/27
Registrant information
Name
Mahdi Noori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3312 7993
Email address
drmahdinoori@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Interferon Alfa-2b in combination with intra-vitreal injection of Bevacizumab in the treatment of diabetic macular edema: a randomized double-blinded clinical trial
Public title
Evaluation of the effect of Interferon Alfa-2b in diabetic macular edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients over 18 years old
Macular edema involving the center.
BCVA between 20/400-40/20
Central macular thickness greater than or equal to 300 μm
Requires 3 IVB injections in the next 12 weeks
Retinal clarity, pupillary dilation for OCT, and necessary cooperation for proper fundus photography
Exclusion criteria:
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
49
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants by covering the bottle containing medicine
Clinical caregiver: keeping the condition of the patient secret before the examination
Evaluator of the outcome: keeping the condition of the patient secret before the examination
Data analyst: keeping the patient's condition secret until the time of analysis
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1149847514
Approval date
2022-09-20, 1401/06/29
Ethics committee reference number
IR.SBMU.MSP.REC.1401.297
Health conditions studied
1
Description of health condition studied
Diabetic macular edema
ICD-10 code
E11. 311
ICD-10 code description
unspecified diabetic retinopathy with macular edema
Primary outcomes
1
Description
Decrease thickness of the central part of the macula
Timepoint
At the beginning of the study and one month after the third injection of bevacizumab
Method of measurement
Oct device (Optical coherence tomography)
Secondary outcomes
1
Description
Improve visual acuity
Timepoint
Before the study and one month after the third injection of bevacizumab
Method of measurement
Optometry
Intervention groups
1
Description
Control group: For this group, in sterile conditions, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed at one-month intervals. In this group, patients will be prescribed placebo (artificial tears) and will be used every 6 hours for 4 months.
Category
Treatment - Drugs
2
Description
Intervention group: For this group, in sterile conditions, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed at one-month intervals. In this group, the interferon α 2b drop (1 MU/Ml) starts immediately after the first injection, and patients use one drop in the affected eye every 6 hours for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Torfeh hospital
Full name of responsible person
Mahdi noori
Street address
Torfeh Hospital, Ibn Sina Street
City
Tehran
Province
Tehran
Postal code
1149847514
Phone
+98 21 7762 6550
Email
torfeHospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdi noori
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 7762 6550
Email
drmahdinoori@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdi noori
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
NO.5, Mostajabi Street, Iran Street
City
Tehran
Province
Tehran
Postal code
1157734361
Phone
+98 21 3312 7993
Email
drmahdinoori@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdi noori
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No.5, Mostajabi Street, Iran Street
City
Tehran
Province
Tehran
Postal code
1157734361
Phone
+98 21 3312 7993
Email
drmahdinoori@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdi noori
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No. 5, Mostajabi Alley, Iran St
City
Tehran
Province
Tehran
Postal code
1147734361
Phone
+98 21 3312 7993
Email
Drmahdinoori@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after de-identifying individuals
When the data will become available and for how long
After finishing the study
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further research
From where data/document is obtainable
In order to receive the documents, please contact the person in charge of the project (Dr. Mehdi Nouri) (working at Torfeh Hospital) in person or by phone (mobile number 09122000493).
What processes are involved for a request to access data/document
After contacting the official (Mahdi Noori), the requested documents will be sent to the requester