The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema
Primary Purpose
Uveitis, Cystoid Macular Edema
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Diclophenac
Triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis
Eligibility Criteria
Inclusion Criteria:
- cystoids macular edema which is diagnosed by OCT and flurocein angiography
- 5/200 < Visual acuity < 20/50
- resistance to routine treatment (oral treatment, periocular injection)
Exclusion Criteria:
- history of retinal disease cause macular edema like diabetes
- arterial occlusion
- monocular patients
- patients candidate for intra-ocular operation
- history of glaucoma or ocular hypertension
- any cataract that would interfere with OCT
Sites / Locations
- Ophthalmic Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diclophenac
Triamcinolone
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00893854
First Posted
May 4, 2009
Last Updated
May 4, 2009
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00893854
Brief Title
The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema
Official Title
The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cystoids macular edema (CME) is one of the most common causes of low vision due to uveitis. The treatment for reducing the intra-ocular inflammation can decrease the macular edema. In some patients, CME persists even after inflammation control, and additional treatment is needed for better vision. Oral steroid, periocular and intravitreal Triamcinolone are the principles in treatment, but some complications like cataracts and increased ocular pressure have been seen. Diclophenac is a non-steroid anti-inflammatory drug that improves the vision and decreases the macular thickness by slowing down the prostaglandin E2 (PGE2) ending in vascular endothelial growth factor (VEGF) inhibition. In this study, the investigators are going to compare the therapeutic affect of intravitreal Diclophenac and Triamcinolone in persistent uveitic cystoids macular edema. Since diclophenac is a cheap and accessible drug in all curative centers it could be applied instead of Triamcinolone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Cystoid Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
Diclophenac
Arm Type
Experimental
Arm Title
Triamcinolone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Diclophenac
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cystoids macular edema which is diagnosed by OCT and flurocein angiography
5/200 < Visual acuity < 20/50
resistance to routine treatment (oral treatment, periocular injection)
Exclusion Criteria:
history of retinal disease cause macular edema like diabetes
arterial occlusion
monocular patients
patients candidate for intra-ocular operation
history of glaucoma or ocular hypertension
any cataract that would interfere with OCT
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
166666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masoud Soheilian, MD
Phone
+98 21 22585952
Email
labbafi@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema
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