To evaluate the therapeutic effects of intra-vitreal injection Bevacizumab combined with Diclofenac-Na versus intra-vitreal Bevacizumab alone in the treatment of naïve diabetic macular edema.
Design
Prospective, randomized, parallel group, interventional clinical practice trial
Settings and conduct
Eye dept. Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex, Nowshera. The trial was non-blinded, prospective interventional study started from Sept. 2020 till March 2021.
Participants/Inclusion and exclusion criteria
The ‘ETDRS’ criteria was utilized for enrollment of treatment naïve eyes of DME, defined as any hard exudates/dot blot hemorrhages, retinal thickening/edema within 500µm from the center of the fovea or involving the very center, examined clinically on fundoscopy Exclusions included: 1) Any history of prior retinal laser therapy 2) History of prior intravitreal injections any type (3) Any intra-ocular procedure done within last 6 months 4) Rubeosis irides 5) Any glaucomatous eye damage 6) evidence of ischemic maculopathy, defined as an enlarged foveal avascular zone (FAZ) ≥ 1500µm; 7) Best corrected VA of ≥ 6/12 or ≤ 6/120; 8) significant media opacity precluding fundus view 9) Associated morbid conditions like, monocularity, pregnancy, diabetic nephropathy grade 3 and HbA1c ≥ 10.
Intervention groups
INTRAVITREAL DICLOFENAC PLUS BEVACIZUMAB (IV-B/D) VERSUS BEVACIZUMAB (IV-B) ALONE
Main outcome variables
Primary outcome variable was Visual acuity in Log MAR
Secondary outcome variable was Central sub-field thickness of Macula
Tertiary variable was Intra-ocular pressure (IOP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220607055097N1
Registration date:2022-06-13, 1401/03/23
Registration timing:retrospective
Last update:2022-06-13, 1401/03/23
Update count:0
Registration date
2022-06-13, 1401/03/23
Registrant information
Name
Adnan Ahmad
Name of organization / entity
Nowshera Medical College, Nowshera
Country
Pakistan
Phone
+92 91 2586506
Email address
dradnanahmad@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-01, 1399/06/11
Expected recruitment end date
2021-03-30, 1400/01/10
Actual recruitment start date
2020-09-01, 1399/06/11
Actual recruitment end date
2021-03-30, 1400/01/10
Trial completion date
2021-10-04, 1400/07/12
Scientific title
COMPARATIVE EVALUATION OF INTRAVITREAL DICLOFENAC PLUS BEVACIZUMAB VERSUS BEVACIZUMAB ALONE IN THE TREATMENT OF NAÏVE DIABETIC MACULAR EDEMA
Public title
INTRAVITREAL DICLOFENAC PLUS BEVACIZUMAB VERSUS BEVACIZUMAB ALONE IN THE TREATMENT OF DIABETIC MACULAR EDEMA
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The ‘ETDRS’ criteria was utilized for enrollment of treatment naïve eyes of DME, defined as any hard exudates/dot blot hemorrhages, retinal thickening/edema within 500µm from the center of the fovea or involving the very center, examined clinically on fundoscopy
Age range from 45 years to 78 years
Type 2 DM
Exclusion criteria:
Any history of prior retinal laser therapy
History of prior intravitreal injections any type
Any intra-ocular procedure done within last 6 months
Rubeosis irides
Any glaucomatous eye damage
evidence of ischemic maculopathy, defined as an enlarged foveal avascular zone (FAZ) ≥ 1500µm;
Best corrected VA of ≥ 6/12 or ≤ 6/120
Significant media opacity precluding fundus view
Associated morbid conditions like, monocularity, pregnancy, diabetic nephropathy grade 3 and HbA1c ≥ 10.
Age
From 45 years old to 78 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
1) Simple Randomization was done
2) Unit of randomization was taken an an individual
3) Computer software based randomization done
4) Allocation concealment was not done
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
None
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethical Review Board of Nowshera Medical College
Street address
Mardan road, near Kabul river, Nowshera
City
Nowshera
Postal code
24110
Approval date
2020-08-24, 1399/06/03
Ethics committee reference number
0386/R&D/IERB/NMC
Health conditions studied
1
Description of health condition studied
Diabetic macular edema
ICD-10 code
E08.341
ICD-10 code description
Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema
Primary outcomes
1
Description
Visual acuity improvement in Log MAR
Timepoint
Baseline, 4th, 12th and 24th week
Method of measurement
Visual acuity was measured with Snellen charts charts and than converted into Log. of minimum angle of resolution (Log MAR) units
Secondary outcomes
1
Description
Central sub-field thickness of macula
Timepoint
Baseline, 4th, 12th and 24th week
Method of measurement
Macular thickness was measured in microns
Intervention groups
1
Description
Intervention group: Intravitreal Bevacizumab and Diclofenac (IV-B/D) Vs Intravitreal Bevacizumab alone (IV-B)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex
Full name of responsible person
Mubashir Rehman
Street address
Mardan road, near Kabul river, Nowshera
City
Nowshera
Postal code
24110
Phone
+92 923 9220325
Email
info@nmcn.edu.pk
Web page address
https://nmcn.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex
Full name of responsible person
Nizam Darwesh
Street address
Mardan road, near Kabul river, Nowshera
City
Nowshera
Postal code
24110
Phone
+92 923 9223025
Email
info@nmcn.edu.pk
Web page address
https://nmcn.edu.pk/
Grant name
None
Grant code / Reference number
None
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex
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
Nowshera Medical College
Full name of responsible person
Nizam Darwesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Community Eye research
Street address
Mardan road, near Kabul river, Nowshera
City
Nowshera
Province
Khyber Pukhtoonkhwa
Postal code
24110
Phone
+92 923 9220325
Email
drnizam@yahoo.co.uk
Web page address
https://nmcn.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nowshera Medical College
Full name of responsible person
Adnan Ahmad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cornea and Medical Retina
Street address
Civil colony, Kohat road
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25000
Phone
+92 91 2586506
Email
dradnanahmad@hotmail.com
Web page address
https://nmcn.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
Nowshera Medical College
Full name of responsible person
Adnan Ahmad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Civil colony, Kohat road
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25000
Phone
+92 91 2586506
Email
dradnanahmad@hotmail.com
Web page address
https://nmcn.edu.pk/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidential
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
1) IPD regarding Visual acuity in Log MAR
2) IPD regarding Macular thickness in microns
When the data will become available and for how long
Data is available
To whom data/document is available
People working in Academic Institutions
Under which criteria data/document could be used
For conducting further research in this field to explore more knowledge