Evaluation of the effect of intravitreal propranolol on macular thickness.
Evaluation of the effect of intravitreal propranolol on improving the vision of patients.
Evaluation of possible ocular and systemic side effects following intravitreal injection of propranolol.
Design
Single arm phase 2 clinical trial on 10 patients
Settings and conduct
This study will be conducted as a pilot study of patients. A number of patients with treatment-resistant diabetic macular edema, who have previously been treated with Avastin and have not recovered adequately, are subjected to intravitreal injection of propranolol, and their response to treatment is evaluated compared to before treatment with propranolol. . 10 patients will be included in the study as a pilot. Patients must have at least 9 intravitreal injections of bevacizumab on a monthly basis, and if there is no adequate response, (reduction of 30% or less than one millimeter central thickness of the macula), they will enter the study and the effects of intravitreal injection of propanolol on reducing the thickness and removing edema The macular area will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with chronic and refractory DME who have been treated with Avastin at least nine times.
Exclusion criteria: 1- Patients who do not have proper follow-up for diabetic retinopathy
2-Patients without diet and medication for diabetes treatment
3-end stage patients for diabetic retinopathy (legal blindness, neovascular glaucoma, retinal tear, etc.)
Intervention groups
Diabetic patients with treatment-resistant macular edema
Main outcome variables
The possibility of improvement of macular edema in diabetic patients resistant to Avastin
The possibility of improvement of edema in patients with treatment-resistant macular edema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231027059872N1
Registration date:2024-06-15, 1403/03/26
Registration timing:retrospective
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
mohammad reza neusha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3657 5609
Email address
mreza63neusha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravitreal propranolol in patient with persistent clinically significant diabetic macular edema: A single Armed Clinical Trial
Public title
Intravitreal propranolol in patient with persistent clinically significant diabetic macular edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic and refractory DME who have been treated with Avastin at least nine times.
Exclusion criteria:
Patients who do not have proper follow-up for diabetic retinopathy
Patients without diet and medication for diabetes treatment
end stage patients for diabetic retinopathy (legal blindness, neovascular glaucoma, retinal tear, etc.)
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research and Technology Vice-Chancellor،Central Building No. 2, 3rd Floor, Tabriz University of Medical Science,Golgasht st
City
TABRIZ
Province
East Azarbaijan
Postal code
5165665811
Approval date
2022-07-11, 1401/04/20
Ethics committee reference number
IR.TBZMED.REC.1402.435
Health conditions studied
1
Description of health condition studied
Refractory 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
The thickness of the macula is normally between 228-330 micrometers. This value increases in patients with diabetic macular edema. In this study, we expect the central thickness of the macula to decrease by about 100 microns.
Timepoint
1week/4week/8week
Method of measurement
Optical coherence tomography (oct)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: diabetic patients resistant to routine medical treatment (bevacizumab). Control group: the same patients with macular edema treated before propranolol injection. For patients in the intervention group, before entering the study, a complete eye examination including best vision with BCVA correction and retinal examination after pupil dilation with 1% tropicamide drops and then oct is performed to determine the thickness of the retina in the macula area. For patients who are included in the intervention group, one dose of propranolol 1 mg intravitreous ampoule with a concentration of 50 micrograms in 0.5 ml from Rooz Daro Company in the eye operating room at Nikokari Ophthalmology Hospital in Tabriz, after washing with diluted betadine It is injected under local anesthesia.Then the day after the injection, one month after the injection, and finally 3 months after the injection, he underwent a complete re-examination, including the best visual acuity with correction, retinal examination after pouring 1% tropicamide drops, and doing oct to determine the thickness of the retina in the posterior macula area. They are placed from the injection. We expect that the thickness of the macula will decrease by about 100 microns after propranolol injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
nikookary Eye Hospital
Full name of responsible person
Dr. Akam salehi/ Dr Mohammareza Neusha
Street address
Abbasi ST , Nikookari Eye Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5157655116
Phone
+98 41 3657 7331
Email
seyvan8@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahaabi
Street address
University ST / Tabriz. University Research and Development Complex/ Department of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3337 3446
Email
mededu@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Akam salehi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi st/ Nikookari eye hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7331
Email
seyvan8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammareza Neusha
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi ST , Nikookari Eye Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
0098 41 36577331-3
Email
mreza63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Akam Salehi
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi ST , Nikookari Eye Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
0098 41 36577331-3
Email
Seyvan8@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available