The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Shahid Beheshti University of Medical Sciences
Information provided by:
Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00893854
First received: May 4, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uveitis Cystoid Macular Edema |
Drug: Diclophenac Drug: Triamcinolone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema |
Resource links provided by NLM:
MedlinePlus related topics:
Edema
Drug Information available for:
Triamcinolone diacetate
Triamcinolone acetonide
Triamcinolone
Triamcinolone hexacetonide
Diclofenac sodium
Diclofenac potassium
Diclofenac
U.S. FDA Resources
Further study details as provided by Shahid Beheshti University of Medical Sciences:
| Arms | Assigned Interventions |
|---|---|
| Experimental: Diclophenac | Drug: Diclophenac |
| Experimental: Triamcinolone | Drug: Triamcinolone |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893854
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893854
Locations
| Iran, Islamic Republic of | |
| Ophthalmic Research Center | Recruiting |
| Tehran, Iran, Islamic Republic of, 166666 | |
| Contact: Masoud Soheilian, MD +98 21 22585952 labbafi@hotmail.com | |
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
More Information
| ClinicalTrials.gov Identifier: | NCT00893854 History of Changes |
| Other Study ID Numbers: | 8727 |
| Study First Received: | May 4, 2009 |
| Last Updated: | May 4, 2009 |
| Health Authority: | Iran: Ethics Committee |
Additional relevant MeSH terms:
|
Edema Macular Edema Uveitis Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Uveal Diseases Diclofenac Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on September 27, 2016