The effect of bevacizumab and aflibercept in the treatment and outcome of patients with retinopathy of prematurity
Design
A clinical trial with parallel groups
Settings and conduct
50 patients are involved in this study. There are 25 people in each group. Bevacizumab is given to one group and aflibercept to the other group. It is performed in Zahra Zahedan Ophthalmology Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
- Completion of patient files, patients who need treatment, patients who need treatment with anti-VEGF drugs
- Exit criteria include:
Patients with underlying disease, including congenital glaucoma, congenital cataract, as well as patients with vitreous and retinal hemorrhages unrelated to ROP.
Intervention groups
In the first group, they receive bevacizumab manufactured by Ariogen Pharmed with a dose of 0.05 ml from a vial of 100 mg/4 ml. In the second group, they receive aflibercept drug manufactured by Bayer AG in Germany with a dose of 0.05 ml from a vial of 4 mg/ml.
Main outcome variables
Improving the function of the pupil and retina
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240611062093N1
Registration date:2024-08-08, 1403/05/18
Registration timing:prospective
Last update:2024-08-08, 1403/05/18
Update count:0
Registration date
2024-08-08, 1403/05/18
Registrant information
Name
Ebrahim Rohoolamini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3232 6423
Email address
ebrahimrohoolamini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-20, 1403/05/30
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of bevacizumab and aflibercept in the treatment and outcome of patients with retinopathy of prematurity (ROP)
Public title
Comparing the effects of bevacizumab and aflibercept in the treatment and outcome of patients with retinopathy of prematurity (ROP)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Completion of patient files
Patients who need treatment
Patients needing treatment with anti-VEGF drugs
Exclusion criteria:
Patients with underlying disease, including congenital glaucoma, congenital cataract
Patients with vitreous hemorrhages
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The type of randomization is simple randomization. Using the table of random numbers, it will continue until the completion of the sample size in each group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In the present study, the doctor, researcher and patients will be blinded to the study groups. Both bevacizumab and aflibercept drugs are in the form of ampoules and their preparation is done by nurses before injecting them into patients. The ampoules are given by the nurse to the researcher and the doctor for injection to the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2024-05-12, 1403/02/23
Ethics committee reference number
IR.ZAUMS.REC.1403.096
Health conditions studied
1
Description of health condition studied
Retinopathy of prematurity
ICD-10 code
H35.1
ICD-10 code description
Retinopathy of prematurity
Primary outcomes
1
Description
Improve pupil function
Timepoint
2 weeks, 1 month and 3 months after the intervention
Method of measurement
Pupil dilation
2
Description
Improve retinal function
Timepoint
2 weeks, 1 month and 3 months after the intervention
Method of measurement
Complete retinal examination
Secondary outcomes
empty
Intervention groups
1
Description
Bevacizumab is an anti-angiogenic drug with a protein structure with a molecular weight of 149 kilodaltons manufactured by Ariogen Pharmed Company with a concentration of 4.100 ml in each vial and is injected into the vitreous with a dose of 0.05 ml. Drug injection is performed in the operating room under sedation under the supervision of an anesthesiologist. Before the injection, first the skin of the eyelid and around the eyes are disinfected with 10% betadine for 90 seconds, then the infant speculum is placed, and the surface of the eye is disinfected with 5% betadine for 30 seconds, and then the injection is made with a 1cc insulin syringe. It is injected into the vitreous with a 30 gauge at a distance of 1.5 mm from the limbus in the supratemporal area of the eye. Babies are discharged 2 hours after the injection, and two weeks later, the retina is re-examined in terms of the response to the treatment. will be evaluated.
Category
Treatment - Drugs
2
Description
Control group: Aflibercept drug is a soluble protein with a molecular weight of 115 kilodaltons with anti-angiogenic activity. this The drug is manufactured by Bayer AG, Germany, and it is in the form of a vial of 40 mg/ml and is injected into the vitreous with a dose of 0.05 ml. Drug injection is performed in the operating room under sedation under the supervision of an anesthesiologist. Before the injection, first the skin of the eyelid and around the eyes are disinfected with 10% betadine for 90 seconds, then the infant speculum is placed, and the surface of the eye is disinfected with 5% betadine for 30 seconds, and then the injection is made with a 1cc insulin syringe. It is injected into the vitreous with a 30 gauge at a distance of 1.5 mm from the limbus in the supratemporal area of the eye. Babies are discharged 2 hours after the injection, and two weeks later, the retina is re-examined in terms of the response to the treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahra Zahedan Ophthalmology Hospital
Full name of responsible person
Ibrahim Ruhol Amini
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
ebrahimrohoolamini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Noor Mohammad Bakhshani
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
ebrahimrohoolamini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Zahedan University of Medical Sciences
Full name of responsible person
Ibrahim Ruhol Amini
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan
City
zahedn
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
ebrahimrohoolamini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ibrahim Ruhol Amini
Position
Medical Sciences Campus, Doctor Hasabi Square, Zahedan
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
ebrahimrohoolamini@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ibrahim Ruhol Amini
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Medical Sciences Campus, Doctor Hasabi Square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
ebrahimrohoolamini@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 is potentially shareable after unidentified individuals
When the data will become available and for how long
Starting 9 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
No other condition is considered
From where data/document is obtainable
ebrahimrohoolamini@gmail.com
What processes are involved for a request to access data/document