Our aim, in this study, is to evaluate the effects of interferon Gamma 1b in the treatment of uveitic cystoid macular edema. Some principal inclusion criteria are, to have uveitis at least 3 months before the participation in the study together with macular cystoid edema secondary to uveitis in at least one eye, Some principal exclusion criteria are pregnancy or breast feeding; occurrence of intolerable adverse effects. Due to a restriction in count of eligible patients, 10 subjects (both males and females) aged between 18 to 60 referring to the ophthalmology clinics of Nikukari hospital , Tabriz, Iran, during a 1 year period starting from 2011-03-11, would be included. A basal Optical Coherence Tomography of the macula will be performed for all the individuals before the administration of the drug and then one drop of considered eye drop containing 10 micrograms in 0.05 ml of interferon Gamma 1b solution (equivalent to mentioned drug's vial concentration) would be instilled in involved eye(s) weekly for 3 weeks. Optical coherence tumography (as a primary outcome measure) would be repeated to obtain the central macular thickness one week after instillation of each dose and 3 months after the instillation of the last dose. In each visit measurement of intraoccular pressure and intraoccular inflammation (as other primary outcome measures) would be checked using tonometer and slit lamp, respectively. Visual acuity (as the secondary outcome measure) will be tested, as well.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105236568N1
Registration date:2011-12-28, 1390/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-28, 1390/10/07
Registrant information
Name
Leila Alizadeh ghavidel
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1655 1332
Email address
alizadehl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-03-11, 1389/12/20
Expected recruitment end date
2012-03-10, 1390/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of topical interferon Gamma 1b in the treatment of uveitic cystoid macular edema
Public title
Interferon Gamma 1b as a treatment for macular edema caused by uveitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (to have medial, posterior or pan-uveitis at least 3 months before the participation in the study together with macular cystoid edema secondary to uveitis in at least one eye; to have visual acuity equal or greater than 20/200; to be 18 to 60 year-old; to have a central macular thickness greater than 250 micrometers)
Exclusion criteria: (pregnancy or breast feeding; occurrence of intolerable adverse effects; to have a history of herpetic kerititis and multiple sclerosis; to have an active infection which needs an urgent treatment; history of chronic or recurrent infections)
Age
From 18 years old to 60 years old
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)
Double 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 Medical University
Street address
Tabriz Medical University, Daneshgah square
City
Tabriz
Postal code
Approval date
2011-03-14, 1389/12/23
Ethics committee reference number
9035
Health conditions studied
1
Description of health condition studied
Uveitic cystoid macular edema
ICD-10 code
H35.8, H20
ICD-10 code description
other specified retinal disorders, uveitis
Primary outcomes
1
Description
Central Macular Thickness
Timepoint
Before the initiation of the intervention, one week after instillation of each dose for 3 weeks, 3 months after the finishing of the study
Method of measurement
Using Optical Coherence Tomography (OCT), micrometer
2
Description
Intraoccular pressure
Timepoint
Before the initiation of the intervention, one week after instillation of each dose for 3 weeks, 3 months after the finishing of the study
Method of measurement
Using tonometer, mmHg
3
Description
Intraoccular inflammation
Timepoint
Before the initiation of the intervention, one week after instillation of each dose for 3 weeks, 3 months after the finishing of the study
Method of measurement
Using slit lamp, mild or moderate or severe
Secondary outcomes
1
Description
Visual acuity
Timepoint
Before the initiation of the intervention, one week after instillation of each dose for 3 weeks, 3 months after the finishing of the study
Method of measurement
Snellen chart, in a fraction of 200
Intervention groups
1
Description
one drop of considered eye drop containing 10 micrograms in 0.05 ml of interferon Gamma 1b solution, weekly for 3 weeks will be instilled in involved eye(s)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Nikukari hospital
Full name of responsible person
MohammadReza Eskandari
Street address
Clinics ward, Nikukari hospital, Abbasi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
AliReza Ostad Rahimi
Street address
Chandler for research,Tabriz Medical University, Daneshgah square
City
Tabriz
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
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
Tabriz Medical University
Full name of responsible person
MohammadReza Eskandari
Position
Ophthalmology resident, student
Other areas of specialty/work
Street address
Nikukari hospital, Abbasi street
City
Tabriz
Postal code
Phone
+98 41 1658 4305
Fax
Email
Mohammad.r.eskandari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
MohammadReza Eskandari
Position
Ophthalmology resident, student
Other areas of specialty/work
Street address
Nikukari hospital, Abbasi street
City
Tabriz
Postal code
Phone
+98 41 1658 4305
Fax
Email
Mohammad.r.eskandari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
MohammadReza Eskandari
Position
Ophthalmology resident, student
Other areas of specialty/work
Street address
Nikukari hospital, Abbasi street
City
Tabriz
Postal code
Phone
+98 41 1658 4305
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)