To evaluate the effect of single dose suprachoroidal triamcinolone acetonide injection combined with three monthly intravitreal injection of bevacizumab on center-involving diabetic macular edema in patients with non-proliferative diabetic retinopathy compared to the control group.
To compare the effects of single dose suprachoroidal triamcinolone acetonide injection combined with three monthly intravitreal injections of bevacizumab with only 3 monthly intravitreal bevacizumab injections on center involving diabetic macular edema in patients with non-proliferative diabetic retinopathy.
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
In this randomized, double-blind, two-arm, parallel-group controlled trial which will be held in Feiz eye hospital, we want to evaluate the effects of injecting a single dose triamcinolone acetonide in suprachoroidal space combined with 3 monthly intravitreal bevacizumab injections in patients with non-proliferative diabetic retinopathy with center involving diabetic macular edema.
Participants/Inclusion and exclusion criteria
Patients with non-proliferative diabetic retinopathy with center involving diabetic macular edema with best corrected visual acuity ≤ 20/40.
Intervention groups
1- In the intervention group, 0.1 cc triamcinolone acetonide will be injected in suprachoroidal space combined with intravitreal bevacizumab in the first injection. Intravitreal bevacizumab alone will be injected in the second and third injections.
2- In the control group, combined with injecting intravitreal bevacizumab, we will enter the suprachoroidal space and exit without injecting any pharmacological agents with the same type of needle used in the intervention group to simulate the intervention in the first injection. Intravitreal bevacizumab alone will be injected in the second and third injections exactly the same as the intervention group.
Main outcome variables
1- Mean changes in best corrected visual acuity
2- Mean changes in central macular thickness
3- Mean changes in central macular volume
4- Mean changes in intraocular pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200314046761N1
Registration date:2020-03-21, 1399/01/02
Registration timing:registered_while_recruiting
Last update:2020-03-21, 1399/01/02
Update count:1
Registration date
2020-03-21, 1399/01/02
Registrant information
Name
Mohammadreza Fazel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 2656
Email address
mr.fazel90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of single dose suprachoroidal triamcinolone acetonide injection combined with three monthly intravitreal injection of bevacizumab on center-involving diabetic macular edema in patients with non-proliferative diabetic retinopathy compared to the control group.
Public title
Effect of single dose suprachoroidal triamcinolone acetonide injection on diabetic macular edema.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-proliferative diabetic retinopathy with center-involving diabetic macular edema with best corrected visual acuity ≤ 20/40.
Patients have not received any interventions (Intravitreal injection, laser, intraocular surgery) 3 months prior to the recruitment.
No history of deep vitrectomy.
Exclusion criteria:
Other comorbid conditions such as CNV, RVO, Glaucoma etc.
Pregnancy
Significant cataract
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
59
More than 1 sample in each individual
Number of samples in each individual:
2
If eligible, each of the eyes of a single patient is included in the trial as one case.
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible eyes were randomly assigned into 2 group ( intervention, control) using random block permutation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
1- At the onset, patients are completely informed about the trial and randomization process and they are blinded to the grouping.
2- The researcher cannot be blinded because he performs all the interventions himself. However, mean best corrected visual acuity changes as the primary outcome are measured by a blinded resident. Central macular thickness (CMT), central macular volume (CMV) etc. as the secondary outcomes are measured by automatic spectral domain optical coherence tomography (SD-OCT) by a trained blinded technician.
3- The statistical analyst is blinded to the grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Isfahan Univerrsity of Medical Sciences (IR.MUI.REC).
Street address
No 84, Asiab Alley, Esta Nazar Street.
City
Isfahan
Province
Isfehan
Postal code
8173655734
Approval date
2019-11-02, 1398/08/11
Ethics committee reference number
IR.MUI.MED.REC.1398.410
Health conditions studied
1
Description of health condition studied
Center-involving diabetic macular edema
ICD-10 code
E08.311
ICD-10 code description
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema.
Primary outcomes
1
Description
Mean change in best corrected visual acuity (BCVA)
Timepoint
Baseline (Day 0), a month after third intravitreal injection (Day 90-95)
Method of measurement
1- Snellen chart 2- Early Treatment Diabetic Retinopathy Study (ETDRS) letters
Secondary outcomes
1
Description
Mean changes in central macular thickness
Timepoint
Baseline (Day 0), a month after third intravitreal injection (Day 90-95)
Method of measurement
Spectral domain optical coherence tomography
2
Description
Mean changes in central macular volume
Timepoint
Baseline (Day 0), a month after third intravitreal injection (Day 90-95)
Method of measurement
Spectral domain optical coherence tomography
3
Description
Mean changes in intraocular pressure
Timepoint
Baseline (Day 0), day 30, a month after third intravitreal injection (Day 90-95)
Method of measurement
Applanation tonometry
Intervention groups
1
Description
Intervention group: Single dose suprachoroidal triamcinolone acetonide (4 mg / 0.1 cc) injection using custom made needle + intravitreal bevacizumab (1.25 mg / 0.1 cc) injections for 3 consecutive months
Category
Treatment - Drugs
2
Description
Control group: simulating suprachoroidal injection (entering the suprachoroidal space and exiting without injecting any pharmacological agents with the same type of needle used in the intervention group) in the first injection + intravitreal bevacizumab (1.25 mg / 0.1 cc) injections for 3 consecutive months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz eye hospital
Full name of responsible person
Dr.Farhad Fazel, Dr.Mohammadreza Fazel
Street address
Feiz eye hospital, Modarres Street
City
Isfahan
Province
Isfehan
Postal code
8173655734
Phone
+98 31 3445 2032
Email
mr.fazel90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Shaghaygh Haghjoo Javanmard
Street address
No 84, Asiab Alley, East Nazar Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8173655734
Phone
+98 31 3629 2656
Email
mr.fazel90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Farhad Fazel, Dr.Mohammadreza Fazel
Position
Associate professor of Ophthalmolgy, Resident of ophthalmolgy
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
No 84, Asiab Alley, East Nazar Street
City
Isfahan
Province
Isfehan
Postal code
8173655734
Phone
+98 31 3629 2656
Email
mr.fazel90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Farhad Fazel, Dr.Mohammadreza Fazel
Position
Associate professor of Ophthalmolgy, Resident of ophthalmolgy
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
No 84, Asiab Alley, East Nazar Street
City
Isfahan
Province
Isfehan
Postal code
8173655734
Phone
+98 31 3629 2656
Email
mr.fazel90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Fazel
Position
Resident of Ophthalmology
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No 84, Asiab alley, east Nazar street,
City
Isfahan
Province
Isfehan
Postal code
8173655734
Phone
+98 31 3629 2656
Fax
Email
mr.fazel90@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After the patients have been unrecognized, full data can be shared.
When the data will become available and for how long
The requests will be accepted at least 6 months after publishing the last results.
To whom data/document is available
Researchers in the field of ophthalmology
Under which criteria data/document could be used
-
From where data/document is obtainable
Mohammadeza Fazel
What processes are involved for a request to access data/document
Sending an email including the reason of request and personal curriculum vitae.