Uveitis is inflammation of uveal tract and adjacent structures. Cystoid macular edema (CME) is a common cause of visual loss in uveitic eyes. Although the pathogenesis of CME in uveitis is not understood completely, Vascular Endothelial Growth Factors (VEGF) are pro-inflammatory cytokines that mediate active intraocular inflammation and is suggested as cause of CME. Bevacizumab (Avastin) is a recombinant humanized anti-VEGF monoclonal antibody approved by the Food and Drug Administration for the treatment of metastatic colorectal cancer. Recently, preliminary studies have indicated desirable effects of intravitreal injection of bevacizumab (IVB) for uveitic CME without significant ocular complications. In this study, we are going to evaluate the long-term outcome of intravitreal bevacizumab in the treatment of refractory uveitic macular edema
In a prospective clinical trial consecutive 30 patients with uveitis and CME were referred to Motahhari uveitis clinic will be enroll in the study.
None of the patients will have a systemic or an ocular disease other than the one causing uveitis.
Patients with history of other diseases causing macular edema (such as diabetes mellitus and retinal vein occlusions) will be excluded from the study.
All of the patients should have decreased vision due to Cystoid Macular Edema (CME), diagnosed by clinic and confirmed by Optical Coherence Tomography, and non-responding to conventional topical medication such as corticosteroids.
so we will determine best corrected visual acuity with logMAR and centeral macular thickness(CMT) by SD- OCT of macula,then will inject 1.25 mg intravitreal bevacizumab.
we will determine visual acuity and OCT of macula after injection to see any improvement.
All selected patients will be under follow up 1month, 3months, 6months and then 1 year after injection by best corrected visual acuity and SD-OCT.
purpose:To determine the long-term safety and efficacy of intravitreal bevacizumab for the treatment of macular edema secondary to uveitis According to sex and age and type of uveitis and best corrected visual acuity (BCVA) gain and optical coherence tomography (OCT) measurements
General information
Acronym
CME : cystoid macular edema
IRCT registration information
IRCT registration number:IRCT138902113846N1
Registration date:2014-06-07, 1393/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-07, 1393/03/17
Registrant information
Name
Mansour Rahimi
Name of organization / entity
SUMS
Country
Iran (Islamic Republic of)
Phone
+98 71116279373
Email address
mrahimi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravitreal bevacizumab(Avastin) for macular edema secondary to uveitis: 1 year results of a prospective pilot study
Public title
Intravitreal bevacizumab(Avastin) for macular edema secondary to uveitis: 1 year results of a prospective pilot study
Purpose
Treatment
Inclusion/Exclusion criteria
In a prospective clinical trial consecutive 30 patients with uveitis and CME will be enroll in the study. None of the patients will have a systemic or an ocular disease other than the one causing uveitis.
Patients with history of other diseases causing macular edema (such as diabetes mellitus and retinal vein occlusions) will be excluded from the study. All of the patients should have decreased vision due to Cystoid Macular Edema (CME),
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences , Zand Street
City
Shiraz
Postal code
Approval date
2013-11-20, 1392/08/29
Ethics committee reference number
ct-p-92-4883
Health conditions studied
1
Description of health condition studied
Macular edema secondary to uveitis
ICD-10 code
H35.8
ICD-10 code description
Other specified retinal disorders
Primary outcomes
1
Description
Best corrected visual acuity
Timepoint
Before injection and 1, 3, 6 and 12 months after injection
Method of measurement
Standard snelen chart and log mar
2
Description
Central macular thickness
Timepoint
Before injection and 1, 3, 6 and 12 months after injection
Method of measurement
SD-OCT
Secondary outcomes
1
Description
Complication of intravitreal injection of bevacizumab
Timepoint
During 1 year after injection
Method of measurement
Routine physical examination
Intervention groups
1
Description
intra vitreal injection of bevacizomab(avastin)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Uveitis Clinic of Motahari Polyclinic
Full name of responsible person
Rahimi Mansour MD
Street address
Motahari Polyclinic, Namazi square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
Shiraz University of Medical Sciences , Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Dr. Hooman Razmi
Position
MD, resident of ophthalmology
Other areas of specialty/work
Street address
Department of ophthalmology, Khalili hospital, Khalili Avenue
City
Shiraz
Postal code
Phone
+98 71 1627 1382
Fax
Email
hooman2482@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mansour Rahimi
Position
Assistant of professor of ophthalmology
Other areas of specialty/work
Street address
Department of ophthalmology, Khalili hospital, Khalili Avenue
City
Shiraz
Postal code
Phone
+98 71 1627 1382
Fax
Email
mrahimi@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
Dr. Hooman Rrazmi
Position
MD, resident of ophthalmology
Other areas of specialty/work
Street address
Department of ophthalmology, Khalili hospital, Khalili Avenue
City
Shiraz
Postal code
Phone
+98 71 1627 1382
Fax
Email
hooman2482@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)