Evaluation of the effect of topical interferon α2b as a complementary treatment of macular edema of patients with diabetic retinopathy in comparison with placebo, double blind randomized placebo controlled clinical trial
Objectives: to evaluate the effect of topical interferon α2b as a complementary treatment of macular edema of patients with diabetic retinopathy.
Design: randomized, double blind, control with placebo, monocenter, first phase of clinical trial.
Setting and conduct:
population study:
Major Inclusion criteria: patient with diabetic macular edema.
Major Exclusion criteria: patients with positive history of radiotherapy or treatment with immunosuppressive agents; patients with malignancy or who have undergone organ transplant; patients with previous ocular vascular accident; patients who have had cataract surgery in the past 3 months.
Sample size: 50 patients.
Intervention: All patients will be checked for Fasting blood sugar, HbA1C, 2 hour post parandial glucose level. ophthalmic examination will be done for them. They will have macular OCT, fundos photography and flourescine angiography basically and visual acuity will be evaluated. Patients will be divided into 2 groups, they all receive standard treatment of DME ( intravitreal bevacizumab or focal laser). One group of them will receive topical interferon 1 million unit per milliliter as an adjunctive treatment for every 6 hours during 4 weeks and the other will get artificial tear as placebo.
Duration of intervention: 4 weeks.
Main outcome measures: visual acuity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081529370N1
Registration date:2016-10-26, 1395/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-26, 1395/08/05
Registrant information
Name
Aidin Meshksar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 2168
Email address
meshksaray@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shiraz University of Medical Sciences.
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical interferon α2b as a complementary treatment of macular edema of patients with diabetic retinopathy in comparison with placebo, double blind randomized placebo controlled clinical trial
Public title
Clinical trial for evaluation of the effect of topical interferon α2b as a complementary treatment of macular edema of patients with diabetic retinopathy compared with placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with diabetic macular edema.
Exclusion criteria: patients with positive history of radiotherapy or treatment with immunosuppressive agents; patients with malignancy or who have undergone organ transplant; patients with previous ocular vascular accident; patients who have had cataract surgery in the past 3 months.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
patients are divided into intervention and control group by blocked randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand street, Shiraz.
City
Shiraz
Postal code
71348-14336
Approval date
2016-07-23, 1395/05/02
Ethics committee reference number
IR.SUMS.MED.REC.1395.31
Health conditions studied
1
Description of health condition studied
diabetic retinopathy
ICD-10 code
H36.0
ICD-10 code description
Diabetic retinopathy
Primary outcomes
1
Description
macular thickness
Timepoint
before intervention, 4 wks after start of intervention,4 wks after the end of intervention
Method of measurement
hidelberg OCT
2
Description
visual acuity
Timepoint
before intervention, 4 wks after start of intervention
Method of measurement
snellen chart
Secondary outcomes
1
Description
leakage on fluorescein angiography
Timepoint
before intervention, 4 wks after start of intervention
Method of measurement
fluoresceine angiography
Intervention groups
1
Description
Intervention group:The patients in this group receive topical Interferon alpha 2 b with dosage of 1 million unit per milliliter in the same container of placebo,4 times a day. one milliliter of Interferon alpha 2b, 3 million units per milliliter produced by Pooyesh Daru company is combined with 2 milliliters of NaCl 0.09 solution and is kept in refrigerator for 10 days.The patient are examined on the week 2,4,8 during study.
Category
Treatment - Drugs
2
Description
Control group: The patients in this group receive artificial tear as placebo four times a day for 4 weeks and are examined on week 2,4 and 8 during study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari polyclinic of Shiraz University of Medical Sciences
Full name of responsible person
Aidin Meshksar
Street address
otahari polyclinic of Shiraz University of Medical Sciences, Namazi square, Shiraz.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Aidin Meshksar
Position
Ophthalmology Resident
Other areas of specialty/work
Street address
Khalili Hospital, Khalili street, Shiraz
City
Shiraz
Postal code
Phone
+98 713671382
Fax
Email
meshksaray@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Afarid
Position
Vitreoretina Fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1382
Fax
Email
afaridm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Afarid
Position
Vitreoretinal Fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Postal code
71345-1978
Phone
00
Fax
Email
afaridm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)