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The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema
This study is currently recruiting participants.
Verified by Shaheed Beheshti Medical University, May 2009
First Received: May 4, 2009   No Changes Posted
Sponsor: Shaheed Beheshti Medical University
Information provided by: Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00893854
  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 I

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment
Official Title: The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema

Resource links provided by NLM:


Further study details as provided by Shaheed Beheshti Medical University:

Arms Assigned Interventions
Diclophenac: Experimental Drug: Diclophenac
Triamcinolone: Experimental Drug: Triamcinolone

  Eligibility

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
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
Shaheed Beheshti Medical University
  More Information

No publications provided

Study ID Numbers: 8727
Study First Received: May 4, 2009
Last Updated: May 4, 2009
ClinicalTrials.gov Identifier: NCT00893854     History of Changes
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Macular Edema
Triamcinolone Acetonide
Uveitis
Sensory System Agents
Therapeutic Uses
Triamcinolone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Retinal Diseases
Uveal Diseases
Eye Diseases
Cyclooxygenase Inhibitors
Diclofenac
Retinal Degeneration
Macular Degeneration
Enzyme Inhibitors
Triamcinolone diacetate
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on February 08, 2010