Macular edema is the most common cause of visual loss in uveitis which occurs in approximately 33% of the uveitic eyes. VEGF by its angiogenic character, ability to create fenestration between the endothelial cells, formation of vesicular organelles and trans-cellular gaps plays its role in vascular leakage and formation of macular edema. Today, there is no consistent protocol for management of uveitic macular edema. In the present study, we aim to compare the long term effect of bevacizumab versus intravitreal triamcinolone in management of uveitic macular edema. For this purpose eyes from patients with inactive uveitis, who had visual loss due to macular edema and not responding to topical medication such as steroid, will enrolled in this study. The eyes will be randomly divided into two groups; the 1st group will receive 0.05 ml (1.25 mg) intravitreal Bevacizvmab (IVB) and the 2nd group 0.05ml (2mg) Triamcinolone acetonide. Outcome measures will best corrected visual acuity in the form of logarithm of the minimum angle of resolution (log MAR) and central macular thickness by means of OCT at 3, 6, and 12 months after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100930224N1
Registration date:2016-11-27, 1395/09/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-27, 1395/09/07
Registrant information
Name
Behzad Khademi
Name of organization / entity
Shiraz University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 2531
Email address
khademi.behzad@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravitreal injection of bevacizumab and triamcinolone acetonide in the treatment of uveitic macular edema
Public title
Comparison of intravitreal anti-VEGF drug and steroid in the treatment of uveitic macular edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with inactive uveitis, according to sun group classification, who had visual loss due to macular edema (diagnosed by optical coherence tomography (OCT)) and not responding to topical medication such as steroid.
Exclusion criteria included any other ophthalmic disease that causes macular edema (e.g. diabetes, venous occlusive diseases); any intraocular surgery within 3 months of injection; media opacity that hinders assessment of macula by OCT, prior vitrectomy; Glaucoma; ocular hypertension and monocularity.
Age
From 9 years old to 47 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2013-10-26, 1392/08/04
Ethics committee reference number
91-01-01-4883
Health conditions studied
1
Description of health condition studied
Macular edema in uveitic eyes
ICD-10 code
H30.9
ICD-10 code description
Chorioretinal inflammation, unspecified
Primary outcomes
1
Description
Macular thickness
Timepoint
3, 6 and 12 months after injection of drug
Method of measurement
Optical Coherence Tomography
Secondary outcomes
1
Description
Visual acuity
Timepoint
3, 6 and 12 months after injection
Method of measurement
Snellen chart
Intervention groups
1
Description
The eyes will randomly divided into two groups; the 1st group will receive 0.05 ml (1.25 mg) intravitreal Bevacizvmab (IVB).
Category
Treatment - Drugs
2
Description
The eyes will randomly divided into two groups; the 2nd group will recive 0.05ml (2mg) Triamcinolone acetonide intravitreally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Dr. Mansour Rahimi
Street address
Shiraz, Khalili Street, Khalili Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sayed Basir Hashemi
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Grant name
پایان نامه دستیاری
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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. Mansour Rahimi
Position
Ophthalmologist, retina and vitrous fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134997446
Phone
+98 71 3481 4336
Fax
Email
mrahimi@ucla.edu
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
Ophthalmologist, Retina and Vitrous fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134997446
Phone
+98 71 3481 4336
Fax
Email
mrahimi@ucla.edu
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Behzad Khademi
Position
Ophthalmologist
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3481 4336
Fax
Email
khademi.behzad@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)