Purpose: Evaluation of therapeutic of effect intravitreal injection of methotrexate in persistent diabetic macular edema
Design:
Prospective interventional( Clinical trial- Quasi experimental)
participant:42 eyes with resistant diabetic macular edema will receive intraviteral methotrexate
Duration: six month follow up study
intervention: using of intra viteral injection of 400µg MTX in eyes with resistant diabetic macular edema ,BCVA ,central subfleid thickness and macular thickness will be recorded before and 1,3,and 6 months after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610098983N2
Registration date:2016-10-30, 1395/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Mohammad rasoul Sabouri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 6886
Email address
sabouri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect intravitreal injection of methotrexate in persistent diabetic macular edema
Public title
Intravitreal injection of methotrexate in persistent diabetic macular edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patient with central subfleid thickness (CST) More than 250 micrometers.
2. Best corrected visual acuity 20/ 200 and more.
3.lack of one line improvement, at least, in best corrected visual acuity or at least 10% reduction in central subfield thickness after intravitreal injection of three consecutive Bevacizumab and one injection co-administration bevacizumab -triamcinolone every 4-6week intervalor 3 consecutive Bevacizumab every 4 -6 weeks plus macular photouagulation.
4. Lack of traction on the macula, which is identified on clinical examination and OCT
5. Patient who agree entering the study (consent form)
Exclusion criteria :
1. Any previous intraocular surgery that was done in more than 1year ago
2. Any laser photocuagulation treatment in the past 4 months .
3. Need to any intraocular surgery, intraocular injection or laser photocoagulation in the follow-up period .
4. Any traction on the macula which is identified on clinical examination and OCT.
5. No control of blood pressure, blood sugar and blood lipid during study
using of intra viteral injection of 400µg MTX in eyes with resistant diabetic macular edema ,BCVA ,central subfleid thickness and macular thickness will be recorded before and 1,3,and 6 months after injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Mohammad Rasoul Sabouri
Street address
Amiralmomenin Hospital, 17 Shahrivar Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences,Vice chancellor for research
Full name of responsible person
Mrs Susan Komaie
Street address
Guilan University of Medical Sciences, 17 Shahrivar Street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences,Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Mohammad rasoul Sabouri
Position
Assistant Professor
Other areas of specialty/work
Street address
17 Shahrivar Street
City
Rasht
Postal code
Phone
+98 13 3323 6886
Fax
Email
r_sabouri2002@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Mohammad rasoul Sabouri
Position
Assistant Professor
Other areas of specialty/work
Street address
17 Shahrivar Street
City
rasht
Postal code
Phone
+98 13 3323 6886
Fax
Email
sabouri2002@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Shila Kianmehr
Position
MSc
Other areas of specialty/work
Street address
17 Shahrivar Street
City
Rasht
Postal code
Phone
+98 13 3323 6886
Fax
Email
shila.kianmehr@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)