- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00893854
The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema
May 4, 2009 updated by: Shahid Beheshti University of Medical Sciences
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tehran, Iran, Islamic Republic of, 166666
- Recruiting
- Ophthalmic Research Center
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Contact:
- Masoud Soheilian, MD
- Phone Number: +98 21 22585952
- Email: labbafi@hotmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Triamcinolone
|
|
Experimental: Diclophenac
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
May 4, 2009
First Submitted That Met QC Criteria
May 4, 2009
First Posted (Estimate)
May 6, 2009
Study Record Updates
Last Update Posted (Estimate)
May 6, 2009
Last Update Submitted That Met QC Criteria
May 4, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Uveal Diseases
- Macular Degeneration
- Macular Edema
- Edema
- Uveitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Diclofenac
Other Study ID Numbers
- 8727 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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